Data / Medical devices / Orthopedic Manual Surgical Instrument / United States

FDA-registered makers of Orthopedic Manual Surgical Instrument in the United States: 490 establishments

Name: FDA-registered makers of Orthopedic Manual Surgical Instrument in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

490 establishments in the United States are registered with the FDA to make Orthopedic Manual Surgical Instrument (product code LXH). 10 have a 510(k) clearance or PMA approval on file and 39 have a recall event. FDA data exported November 2, 2026.

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Device: Orthopedic Manual Surgical Instrument
Product code: LXH
Country: United States

Makers of Orthopedic Manual Surgical Instrument in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Smith & Nephew Inc.	Mansfield, MA, United States	Manufacturer	2	June 14, 2000	1	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer, Specification developer	1	August 26, 1994	5	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	1	February 1, 1994	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer, Repackager or relabeler	1	January 28, 1994	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	1	January 28, 1994	5	api.fda.gov
RG Medical USA	Mount Juliet, TN, United States	Repackager or relabeler, Specification developer	1	February 1, 1994	0	api.fda.gov
Smith & Nephew Inc.	Andover, MA, United States	Specification developer	1	February 27, 1984	1	api.fda.gov
Stryker Instruments	Portage, MI, United States	Complaint file establishment, Specification developer	1	August 5, 1994	0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer	1	January 28, 1994	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	1	February 22, 1980	0	api.fda.gov
3D Logics LLC	Hillsboro, OR, United States	Contract manufacturer	0		0	api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)	Riviera Beach, FL, United States	Contract manufacturer	0		0	api.fda.gov
3Spine, Inc.	Chattanooga, TN, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
4web Inc.	Frisco, TX, United States	Specification developer	0		0	api.fda.gov
A.M. Surgical, Inc.	Nashua, NH, United States	Specification developer	0		0	api.fda.gov
Accufix Surgical, Inc.	Laramie, WY, United States	Specification developer	0		0	api.fda.gov
Accumedix, Inc.	Libertyville, IL, United States	Contract manufacturer	0		0	api.fda.gov
Acumed LLC	Hillsboro, OR, United States	Manufacturer, Specification developer	0		2	api.fda.gov
Advanced Product Solutions Inc.	Dothan, AL, United States	Contract manufacturer	0		0	api.fda.gov
Advanced Research Medical	Burnsville, MN, United States	Manufacturer	0		0	api.fda.gov
Aegis Meditec, Inc.	Costa Mesa, CA, United States	Specification developer	0		0	api.fda.gov
Aesclepius Corporation	San Diego, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Alden Tool Company, Inc.	Berlin, CT, United States	Contract manufacturer	0		0	api.fda.gov
All Quality & Services, Inc.	Fremont, CA, United States	Contract manufacturer	0		0	api.fda.gov
All Quality & Services, Inc.	Garland, TX, United States	Contract manufacturer	0		0	api.fda.gov
Almark Tool & Manufacturing Company, Inc.	Garwood, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer	0		0	api.fda.gov
Alphatec Spine, Inc.	Louisville, CO, United States	Specification developer	0		0	api.fda.gov
Alto Development Corp.	Farmingdale, NJ, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Alva Prototypes Inc	Pottstown, PA, United States	Contract manufacturer, Remanufacturer	0		0	api.fda.gov
American Benchmark Machine Works	Olympia, WA, United States	Contract manufacturer	0		0	api.fda.gov
Angstrom MFG., Inc.	Sainte Genevieve, MO, United States	Contract manufacturer	0		0	api.fda.gov
Anika Therapeutics, Inc.	Bedford, MA, United States	Specification developer	0		0	api.fda.gov
Aptis Medical, LLC.	Glenview, KY, United States	Manufacturer	0		0	api.fda.gov
Arc Precision	Isanti, MN, United States	Contract manufacturer	0		0	api.fda.gov
Arcamed, LLC	Indianapolis, IN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH - Quakertown	Quakertown, PA, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Elmhurst	Elmhurst, IL, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Escondido LLC	Escondido, CA, United States	Manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH-MedTorque	Kenosha, WI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Argon Medical Devices, Inc.	Wheeling, IL, United States	Contract manufacturer	0		0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	0		2	api.fda.gov
Arthrosurface, Inc.	W Bridgewater, MA, United States	Specification developer	0		0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Astra Orthomed, Inc.	Woodstock, GA, United States	Specification developer	0		0	api.fda.gov
Atlas Spine Inc.	Jupiter, FL, United States	Manufacturer	0		0	api.fda.gov
Aurora Spine, Inc.	Carlsbad, CA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Autocam Medical	Kentwood, MI, United States	Contract manufacturer	0		0	api.fda.gov
Autocam Medical	Plymouth, MA, United States	Contract manufacturer	0		0	api.fda.gov
AVALIGN TECHNOLOGIES, Inc.	Fort Wayne, IN, United States	Specification developer	0		0	api.fda.gov
Axia Orthopedics	Portland, OR, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Able Medical Devices	Marquette, MI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Advanced Machine, Inc.	Winchester, TN, United States	Contract manufacturer	0		0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
American Casting Company	Hollister, CA, United States	Contract manufacturer	0		0	api.fda.gov
Arteriocyte Medical Systems, Inc.	Hopkinton, MA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Arthrex California Technology, Incorporated	Santa Barbara, CA, United States	Manufacturer	0		0	api.fda.gov
Arthrex Logistic Center	Fort Myers, FL, United States	Manufacturer	0		0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
ArthroCare Corporation	Austin, TX, United States	Specification developer	0		1	api.fda.gov
Astura Medical	Irving, TX, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Avitus Orthopaedics, Inc	Shelton, CT, United States	Specification developer	0		0	api.fda.gov
B & G MFG. Co.	Hatfield, PA, United States	Contract manufacturer	0		0	api.fda.gov
B & J Medical LLC	Kendallville, IN, United States	Contract manufacturer	0		0	api.fda.gov
B-One Ortho, Corp.	Cedar Knolls, NJ, United States	Manufacturer	0		0	api.fda.gov
Banister Tool, Inc.	Pflugerville, TX, United States	Contract manufacturer	0		0	api.fda.gov
Biogennix, LLC	Irvine, CA, United States	Specification developer	0		0	api.fda.gov
Biomerieux, Inc.	Hazelwood, MO, United States	Manufacturer for export	0		0	api.fda.gov
Biomet Microfixation	Jacksonville, FL, United States	Manufacturer, Repackager or relabeler, Specification developer	0		2	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	0		34	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Bioseal	Placentia, CA, United States	Contract manufacturer	0		0	api.fda.gov
Boedeker Plastics, Inc.	Shiner, TX, United States	Contract manufacturer	0		0	api.fda.gov
Bone Solutions, Inc.	Colleyville, TX, United States	Manufacturer	0		0	api.fda.gov
Boulder Biomed LLC	Boulder, CO, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Boxspine, LLC	Plymouth, IN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Busse Hospital Disposables	Hauppauge, NY, United States	Manufacturer, Repackager or relabeler	0		1	api.fda.gov
Buxton Biomedical, Inc.	East Hanover, NJ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Betts Precision	Alsip, IL, United States	Contract manufacturer	0		0	api.fda.gov
BioDynamik	Lake Forest, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Brasseler U.S.A. Medical, LLC	Savannah, GA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
C&A Tool Engineering, Inc. Auburn Plant	Auburn, IN, United States	Contract manufacturer	0		0	api.fda.gov
C&W Swiss, Inc.	Clayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Calvary Spine, LLC	Towson, MD, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Camber Spine Technologies	King of Prussia, PA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Carlsmed, Inc.	Carlsbad, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
CATALYST ORTHOSCIENCE Inc	Naples, FL, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Cayenne Medical, Inc.	Scottsdale, AZ, United States	Manufacturer	0		0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer	0		0	api.fda.gov
Centinel Spine, LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Chapman Lake Instrument	Bloomington, IN, United States	Contract manufacturer	0		0	api.fda.gov
Classic Wire Cut Company, Inc.	Valencia, CA, United States	Contract manufacturer	0		0	api.fda.gov
Crossroads Extremity Systems LLC	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
CTL Medical Corporation	Carrollton, TX, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	api.fda.gov
Curiteva, Inc.	Tanner, AL, United States	Contract manufacturer	0		0	api.fda.gov
Curvafix, Inc.	Kirkland, WA, United States	Manufacturer	0		0	api.fda.gov
Cadence Inc.	Staunton, VA, United States	Contract manufacturer	0		0	api.fda.gov
Choice Spine LLC	Knoxville, TN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0		0	api.fda.gov
Composite Manufacturing, Inc.	San Clemente, CA, United States	Contract manufacturer	0		0	api.fda.gov
ConforMIS, Inc.	Wilmington, MA, United States	Manufacturer	0		0	api.fda.gov
Criterion Tool & Die Inc DBA Criterion Precision Machining	Brookpark, OH, United States	Contract manufacturer	0		0	api.fda.gov
Danamed Inc	Charlotte, NC, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Degen Medical	Florence, SC, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Demetra, Inc.	Germantown, TN, United States	Specification developer	0		0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	0		16	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	0		1	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Deroyal Industries, Inc.	Powell, TN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Design Standards Corp.	Charlestown, NH, United States	Contract manufacturer	0		0	api.fda.gov
Diamond Orthopedic	Gastonia, NC, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Disruptive Medtech, LLC	Laramie, WY, United States	Contract manufacturer	0		0	api.fda.gov
Djo, LLC	Carlsbad, CA, United States	Specification developer	0		0	api.fda.gov
Donatelle Plastics, LLC	New Brighton, MN, United States	Contract manufacturer	0		0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	api.fda.gov
DT Medtech LLC	McMinnville, TN, United States	Specification developer	0		0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	0		5	api.fda.gov
Demetra, Inc.	Hudson, MA, United States	Manufacturer	0		0	api.fda.gov
Dev4	Houston, TX, United States	Specification developer	0		0	api.fda.gov
Dunamis Medical LLC	Greenville, AL, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Ebner Medical LLC	Orange Park, FL, United States	Specification developer	0		0	api.fda.gov
Eca Medical Instruments	Newbury Park, CA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Elevation Spine	Monterey, CA, United States	Specification developer	0		0	api.fda.gov
Elmed, Inc.	Glendale Heights, IL, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	0		5	api.fda.gov
Eptam Plastics, Ltd	Northfield, NH, United States	Contract manufacturer	0		0	api.fda.gov
Eptam West LLC	Colorado Springs, CO, United States	Contract manufacturer	0		0	api.fda.gov
Evergreen Orthopedic Research Lab	Kirkland, WA, United States	Specification developer	0		0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer, Repackager or relabeler	0		5	api.fda.gov
Elite Medical, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Elite Medical, LLC	Florence, AL, United States	Contract manufacturer	0		0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Exactech Sarasota	Sarasota, FL, United States	Manufacturer	0		0	api.fda.gov
Expanding Innovations, Inc.	Mountain View, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Extremity Medical, LLC	Parsippany, NJ, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Ferry Machine Corporation	Oakland, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Fetzer Surgical, LLC	Scottsdale, AZ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	api.fda.gov
Flenar Manufacturing LLC	Rochester, IN, United States	Manufacturer	0		0	api.fda.gov
Flexbar Machine Corp.	Islandia, NY, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Flospine LLC	Boca Raton, FL, United States	Manufacturer	0		0	api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower	Horsham, PA, United States	Specification developer	0		1	api.fda.gov
Fluke Metal Products, Inc	Bothell, WA, United States	Contract manufacturer	0		0	api.fda.gov
Fort Wayne Metals Research Products, LLC	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Forum Plastics LLC	Watertown, CT, United States	Contract manufacturer	0		0	api.fda.gov
Fusion Orthopedics Usa, LLC	Mesa, AZ, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Ferry Machine Corporation	Little Ferry, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer, Manufacturer	0		1	api.fda.gov
Genesis Design & Fabrication	Gilbert, AZ, United States	Contract manufacturer	0		0	api.fda.gov
Genesys Spine	Austin, TX, United States	Manufacturer	0		0	api.fda.gov
Geotec, Inc.	Warwick, RI, United States	Contract manufacturer	0		0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0		0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
GLW, Inc.	Englewood Cliffs, NJ, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Gramercy Extremity Orthopedics, LLC.	Richardson, TX, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Granite Forge, LLC	Hudson, NH, United States	Contract manufacturer	0		0	api.fda.gov
Gsource, LLC.	Emerson, NJ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Graham Medical Technologies, L.L.C. d.b.a. GraMedica	Rochester, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Heartwood Enterprises Inc.	Jasper, TN, United States	Contract manufacturer	0		0	api.fda.gov
High-Tech Quality MFG. Inc.	Salt Lake City, UT, United States	Contract manufacturer	0		0	api.fda.gov
Hipp Medical Inc.	Denver, NC, United States	Manufacturer	0		0	api.fda.gov
Holmed LLC	Attleboro, MA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Hoosier, Inc.	Corona, CA, United States	Contract manufacturer	0		0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Manufacturer, Specification developer	0		33	api.fda.gov
Huron Tool & Cutter Grinding	Farmingdale, NY, United States	Contract manufacturer	0		0	api.fda.gov
Haven Manufacturing	Ossian, IN, United States	Contract manufacturer	0		0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	0		0	api.fda.gov
HyperFlex Medical Inc	Richmond, UT, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
I-Tek Medical, Inc.	White Bear Lake, MN, United States	Contract manufacturer	0		0	api.fda.gov
Iconn Orthopedics, LLC	Birmingham, AL, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
In2bones Usa, LLC	Cordova, TN, United States	Manufacturer, Repackager or relabeler	0		1	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
INNO Holdings Inc.	Millcreek, UT, United States	Manufacturer	0		0	api.fda.gov
Innomed, Inc.	Savannah, GA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Instrumental Machine & Development, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Integra Lifesciences Corporation	Cincinnati, OH, United States	Manufacturer	0		0	api.fda.gov
Integrity Orthopaedics, Inc.	Maple Plain, MN, United States	Manufacturer	0		0	api.fda.gov
Intelivation Technologies, LLC	Plymouth Meeting, PA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
International Sterilization Laboratory, LLC	Groveland, FL, United States	Contract sterilizer, Manufacturer for export	0		0	api.fda.gov
Instrumed International Inc dba Avalign German Specialty Instruments	Schaumburg, IL, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
Integra LifeSciences Production Corporation	Mansfield, MA, United States	Specification developer	0		0	api.fda.gov
Integrity Spine	San Antonio, TX, United States	Manufacturer	0		0	api.fda.gov
Intrinsic Therapeutics, Inc.	Woburn, MA, United States	Manufacturer	0		1	api.fda.gov
J&B Precision, Inc.	Cordova, TN, United States	Contract manufacturer	0		0	api.fda.gov
Janco, Inc.	Rollinsford, NH, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
Jatex, Inc.	Nappanee, IN, United States	Contract manufacturer	0		0	api.fda.gov
JB Medical Development, LLC Dba/Md3, LLC	Sunrise, FL, United States	Specification developer	0		0	api.fda.gov
Jewel Precision Sheet Metal & Machining, Inc.	Cedar Grove, NJ, United States	Contract manufacturer	0		0	api.fda.gov
JJJ Medical LLC	Marietta, GA, United States	Manufacturer	0		0	api.fda.gov
JMG Machine, Inc.	La Mirada, CA, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Brandywine)	W Chester, PA, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Elmira)	Horseheads, NY, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	api.fda.gov
Judson A Smith Company	Boyertown, PA, United States	Manufacturer	0		0	api.fda.gov
K2M, Inc.	Leesburg, VA, United States	Complaint file establishment, Manufacturer, Specification developer	0		1	api.fda.gov
Kapstone Manufacturing	Charlotte, NC, United States	Contract manufacturer	0		0	api.fda.gov
Ken-Mar Machine MFG Corp	Paterson, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Keos	Naples, FL, United States	Specification developer	0		0	api.fda.gov
Kinamed, Inc.	Camarillo, CA, United States	Manufacturer	0		0	api.fda.gov
KLS-Martin L.P.	Jacksonville, FL, United States	Specification developer	0		0	api.fda.gov
KMM Group, Ltd	Hatboro, PA, United States	Contract manufacturer	0		0	api.fda.gov
Kalitec Direct LLC DBA Kalitec Medical	Sarasota, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Kyocera Medical Technologies, Inc.	Redlands, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
LAB Medical Manufacturing, Inc.	Billerica, MA, United States	Contract manufacturer	0		0	api.fda.gov
Lacey Manufacturing Company LLC	Bridgeport, CT, United States	Manufacturer	0		0	api.fda.gov
Lavelle Medical LLC	Westford, MA, United States	Contract manufacturer	0		0	api.fda.gov
Lenkbar LLC	Naples, FL, United States	Contract manufacturer	0		0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Life Instrument Corp.	Braintree, MA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Life Science Outsourcing, Inc.	Brea, CA, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Linear Precision, Inc.	Florence, SC, United States	Contract manufacturer	0		0	api.fda.gov
LISI MEDICAL Remmele	Coon Rapids, MN, United States	Contract manufacturer	0		0	api.fda.gov
LaVezzi Precision, Inc	Bloomingdale, IL, United States	Contract manufacturer	0		0	api.fda.gov
Lake Region Medical	Chaska, MN, United States	Contract manufacturer	0		0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Contract manufacturer	0		0	api.fda.gov
Lincotek Medical LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
LinkBio Corp.	Dover, NJ, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Logan Instruments, LLC	Braintree, MA, United States	Contract manufacturer	0		0	api.fda.gov
Macb, LLC	Fairhope, AL, United States	Specification developer	0		0	api.fda.gov
Mack Molding Company	Arlington, VT, United States	Contract manufacturer	0		0	api.fda.gov
Mackay Manufacturing, Inc.	Spokane Valley, WA, United States	Contract manufacturer	0		0	api.fda.gov
Mainstream Medical Devices	Austin, TX, United States	Contract manufacturer	0		0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	api.fda.gov
Mako Surgical Corp.	Weston, FL, United States	Specification developer	0		0	api.fda.gov
Map Medical Solutions, LLC	Twin Falls, ID, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Marrow Access Technologies	Eden Prairie, MN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Marson Medical, Inc.	Paramus, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Mastercraft Medical	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Matrix Machining Technologies, Inc.	Memphis, TN, United States	Contract manufacturer	0		0	api.fda.gov
Maxkron Machine, LLC	Valencia, CA, United States	Contract manufacturer	0		0	api.fda.gov
Maxx Orthopedics Inc.	Norristown, PA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Mcginley Orthopaedic Innovations, Inc	Casper, WY, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Mci Medical Concept Innovation Inc.	Sunrise, FL, United States	Manufacturer	0		0	api.fda.gov
Mclean Medical & Scientific	Saint Paul, MN, United States	Contract manufacturer	0		0	api.fda.gov
Medical Component Specialists	Bellingham, MA, United States	Contract manufacturer	0		0	api.fda.gov
Medical Modeling - A 3D Systems Company	Littleton, CO, United States	Contract manufacturer	0		0	api.fda.gov
Medin Technologies, Inc.	Totowa, NJ, United States	Contract manufacturer	0		0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Complaint file establishment, Specification developer	0		1	api.fda.gov
Medshape, Inc.	Atlanta, GA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0		0	api.fda.gov
Medtronic Puerto Rico Operations Co., Humacao	Humacao, PR, United States	Manufacturer	0		0	api.fda.gov
Meduloc	Del Mar, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Merit Medical Systems, Inc.	South Jordan, UT, United States	Manufacturer	0		0	api.fda.gov
Micro Precision Swiss	Santa Ana, CA, United States	Contract manufacturer	0		0	api.fda.gov
Microaire Surgical Instruments LLC	Charlottesville, VA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0		1	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Mid South Precision	Murfreesboro, TN, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
Mission Surgical Innovations	Raleigh, NC, United States	Specification developer	0		0	api.fda.gov
Mizuho America, Inc.	Union City, CA, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Mizuho Orthopedic Systems, Inc.	Union City, CA, United States	Manufacturer	0		1	api.fda.gov
MOMANTECH, Inc.	Sheridan, MT, United States	Contract manufacturer	0		0	api.fda.gov
Mount MFG	Marquette, MI, United States	Contract manufacturer	0		0	api.fda.gov
Moximed, Inc.	Fremont, CA, United States	Manufacturer	0		0	api.fda.gov
Mainstay Medical (MML US, Inc.)	San Diego, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Medartis Inc.	Warsaw, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Reprocessor	0		1	api.fda.gov
Mendell	Lakeville, MN, United States	Contract manufacturer	0		0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	api.fda.gov
Microcision LLC	Pennsauken, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
Nanova Biomaterials Inc	Columbia, MO, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Nanovis Spine, LLC	Columbia City, IN, United States	Specification developer	0		0	api.fda.gov
Native Orthopaedics	Providence, RI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Neuroenterprises LLC	Chicago, IL, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Next Generation Tooling Inc	Akron, OH, United States	Contract manufacturer	0		0	api.fda.gov
Nexus Spine, L.L.C.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Nexus Spine, LLC.	Lehi, UT, United States	Specification developer	0		0	api.fda.gov
Ngage Medical Manufacturing	Hernando, MS, United States	Contract manufacturer	0		0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Novabone Products, LLC	Alachua, FL, United States	Manufacturer	0		0	api.fda.gov
Novus Manufacturing Solutions	Murfreesboro, TN, United States	Contract manufacturer	0		0	api.fda.gov
Nuell, Inc.	Leesburg, IN, United States	Contract manufacturer	0		0	api.fda.gov
Nutech Spine, Inc.	Birmingham, AL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Nuvasive, Inc.	Guaynabo, PR, United States	Manufacturer	0		0	api.fda.gov
Nuvasive, Inc.	San Diego, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Nvision Biomedical Technologies, Inc	San Antonio, TX, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
NanoHive Medical LLC	Woburn, MA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
NuVasive Specialized Orthopedics, Inc.	Audubon, PA, United States	Manufacturer	0		0	api.fda.gov
Nypro Inc (Maple Grove)	Maple Grove, MN, United States	Contract manufacturer	0		0	api.fda.gov
Oberg Medical Products Company	Sarver, PA, United States	Contract manufacturer	0		0	api.fda.gov
Odyssey Medical Technologies, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Orthopedics-Chelsea	Chelsea, MI, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Orthopedic Generations LLC	Mokena, IL, United States	Specification developer	0		0	api.fda.gov
Orthotin LLC	Denville, NJ, United States	Manufacturer	0		0	api.fda.gov
Osseointegration International, Inc.	New York, NY, United States	Specification developer	0		0	api.fda.gov
Osseus Fusion Systems LLC	Dallas, TX, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Osteomed	Addison, TX, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Overture Orthopaedics	Irvine, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
Omnia Medical	Morgantown, WV, United States	Specification developer	0		0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	api.fda.gov
OrthAlign, Inc.	Irvine, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Orthopedic Designs North America, Inc.	Tampa, FL, United States	Manufacturer	0		0	api.fda.gov
Ortoway LLC	Horsham, PA, United States	Contract manufacturer	0		0	api.fda.gov
P1 Technologies, Inc.	Cave Spring, VA, United States	Contract manufacturer	0		0	api.fda.gov
Pace Surgical	Malvern, PA, United States	Specification developer	0		0	api.fda.gov
Pacific Instruments Inc.	Honolulu, HI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Packaging Compliance Medical, LLC	Kentwood, MI, United States	Contract manufacturer	0		0	api.fda.gov
Panorthopaedics, Inc.	Atlanta, GA, United States	Specification developer	0		0	api.fda.gov
Paradigm Biodevices, Inc.	Rockland, MA, United States	Specification developer	0		0	api.fda.gov
Paragon 28	Englewood, CO, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Parcus Medical, L.L.C.	Sarasota, FL, United States	Manufacturer	0		0	api.fda.gov
Perryman Company	Houston, PA, United States	Contract manufacturer	0		0	api.fda.gov
Phoenix Instruments, Inc.	Lisle, IL, United States	Contract manufacturer	0		0	api.fda.gov
Phoenix Medical Products, Inc.	Mountain City, TN, United States	Contract manufacturer	0		0	api.fda.gov
Pilotis Tech LLC	Brookhaven, GA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	api.fda.gov
Precision Forms, Inc.	Butler, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Precision Identity Corp. / Kamber	Campbell, CA, United States	Contract manufacturer	0		0	api.fda.gov
Precision Medical Industries	Albion, IN, United States	Contract manufacturer	0		0	api.fda.gov
Precision Medical Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Precision Medical Technologies	Rome City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Primordial Soup, LLC	Saint Paul, MN, United States	Contract manufacturer	0		0	api.fda.gov
Pro Surgical, Inc.	Carlsbad, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Inc.	Castleton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Pioneer Surgical Technology, Inc.	Marquette, MI, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Precision Edge Surgical Products Co LLC	Boyne City, MI, United States	Contract manufacturer	0		0	api.fda.gov
Precision Edge Surgical Products, LLC	Angola, IN, United States	Contract manufacturer	0		0	api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing Facility	N Manchester, IN, United States	Contract manufacturer	0		0	api.fda.gov
Precision Spine, Inc.	Pearl, MS, United States	Manufacturer	0		0	api.fda.gov
Primo Medical Group, INC	Stoughton, MA, United States	Contract manufacturer	0		0	api.fda.gov
ProMed Concepts, LLC	Brighton, TN, United States	Contract manufacturer	0		0	api.fda.gov
ProNuVis LLC	Gastonia, NC, United States	Manufacturer	0		0	api.fda.gov
Promethean Restorative Inc.	Castle Rock, CO, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Quadm Technologies, LLC	Hamilton, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	api.fda.gov
R.K. Manufacturing	Danbury, CT, United States	Contract manufacturer	0		0	api.fda.gov
Ram Precision Industries Inc	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Red Star Contract Manufacturing Inc.	Larwill, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer	0		0	api.fda.gov
Remington Medical, Inc.	Alpharetta, GA, United States	Contract manufacturer	0		0	api.fda.gov
Renovo, Inc.	Bend, OR, United States	Reprocessor	0		0	api.fda.gov
Reselute	Durham, NC, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Responsive Arthroscopy	Minneapolis, MN, United States	Specification developer	0		0	api.fda.gov
Retropsoas Technologies, LLC	Frontenac, MO, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	api.fda.gov
RMS Co.	Minneapolis, MN, United States	Contract manufacturer	0		0	api.fda.gov
Rog Sports Medicine, Inc.	Orland Park, IL, United States	Specification developer	0		0	api.fda.gov
RSB Spine LLC.	Wooster, OH, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)	Alachua, FL, United States	Specification developer	0		0	api.fda.gov
Remington Medical, Inc.	Alpharetta, GA, United States	Contract manufacturer	0		0	api.fda.gov
Resonetics, LLC	Bethel, CT, United States	Contract manufacturer	0		0	api.fda.gov
S.S. White Technologies, Inc. / Dba Shukla Medical	St Petersburg, FL, United States	Contract manufacturer, Manufacturer, Specification developer	0		0	api.fda.gov
Salvin Dental Specialties, LLC	Charlotte, NC, United States	Specification developer	0		0	api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.	Somerset, WI, United States	Contract manufacturer	0		0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Seaspine Orthopedics Corporation	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Seaway Plastics Engineering, LLC	Brooksville, FL, United States	Contract manufacturer	0		0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	0		0	api.fda.gov
Shine Medical, LLC	Lakeland, FL, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Si-Bone, Inc.	Santa Clara, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Si-Bone, Inc.	Santa Clara, CA, United States	Manufacturer	0		0	api.fda.gov
SIGN Fracture Care International	Richland, WA, United States	Manufacturer	0		0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Skeletal Dynamics, Inc	Miami, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		9	api.fda.gov
SONEX HEALTH, Inc	Eagan, MN, United States	Complaint file establishment, Specification developer	0		1	api.fda.gov
SPEC Engineering Co.	Hawthorne, CA, United States	Contract manufacturer	0		0	api.fda.gov
Spinal Elements, Inc.	Carlsbad, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Spinal Simplicity, LLC	Overland Park, KS, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Spine Wave, Inc.	Shelton, CT, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Spinecraft LLC	Westmont, IL, United States	Manufacturer, Specification developer	0		0	api.fda.gov
SPINEFRONTIER, INC. DBA LESspine Innovations	Burlington, MA, United States	Manufacturer	0		3	api.fda.gov
Spineology Inc.	Saint Paul, MN, United States	Manufacturer	0		2	api.fda.gov
Starr Frame LLC	Richardson, TX, United States	Specification developer	0		0	api.fda.gov
Steris Corporation	Montgomery, AL, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
STERIS Corporation	Saint Louis, MO, United States	Manufacturer	0		0	api.fda.gov
Sterramed Inc	Weehawken, NJ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Structure Medical, LLC.	Naples, FL, United States	Contract manufacturer	0		0	api.fda.gov
Stryker Puerto Rico, LLC.	Arroyo, PR, United States	Contract manufacturer	0		0	api.fda.gov
Stryker Spine	Allendale, NJ, United States	Complaint file establishment, Specification developer	0		18	api.fda.gov
Subchondral Solutions	Costa Mesa, CA, United States	Specification developer	0		0	api.fda.gov
Summit MFG. And Machining, Inc.	Bremen, IN, United States	Contract manufacturer	0		0	api.fda.gov
Suretek Medical	Greenville, SC, United States	Reprocessor	0		0	api.fda.gov
Surgentec LLC	Boca Raton, FL, United States	Manufacturer	0		0	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	0		0	api.fda.gov
Surgical Republic	Huntington Beach, CA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Structure Medical, LLC.	Mooresville, NC, United States	Contract manufacturer	0		0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	0		5	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0		0	api.fda.gov
Technical Manufacturing West, LLC	Valencia, CA, United States	Contract manufacturer	0		0	api.fda.gov
Tecomet, Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Tedan Surgical Innovations, Inc.	Sugar Land, TX, United States	Repackager or relabeler, Specification developer	0		3	api.fda.gov
Tensor Surgical, Inc.	Las Vegas, NV, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
The Anspach Effort, Inc.	Palm Bch Gdns, FL, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
The Mill-Rose Company	Mentor, OH, United States	Contract manufacturer	0		0	api.fda.gov
The Orthopaedic Implant Company	Reno, NV, United States	Specification developer	0		0	api.fda.gov
Theken Companies, LLC	Akron, OH, United States	Specification developer	0		1	api.fda.gov
Theramicro	Cordova, TN, United States	Specification developer	0		0	api.fda.gov
Thompson Mis	Sandown, NH, United States	Specification developer	0		0	api.fda.gov
Thompson Surgical Instruments, Inc.	Traverse City, MI, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Tigon Medical LLC	Millersville, MD, United States	Manufacturer, Specification developer	0		0	api.fda.gov
TMJ Solutions, LLC	San Buenaventura, CA, United States	Contract manufacturer	0		0	api.fda.gov
TOMZ Corporation	Berlin, CT, United States	Contract manufacturer	0		0	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	Specification developer	0		0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	0		3	api.fda.gov
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Tracer Orthopedics	Oakland, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Trax Surgical, Inc.	Stoughton, MA, United States	Manufacturer	0		0	api.fda.gov
Treace Medical Concepts, Inc.	Ponte Vedra, FL, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Triangle Machine, Inc.	South Bend, IN, United States	Manufacturer	0		0	api.fda.gov
Triangle Manufacturing Co., Inc.	Upper Saddle River, NJ, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Trice Medical	Malvern, PA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Trident Manufacturing, Inc.	Pingree Grove, IL, United States	Contract manufacturer	0		0	api.fda.gov
Trigon America LLC	Aurora, IL, United States	Contract manufacturer	0		0	api.fda.gov
Trimed, Inc.	Santa Clarita, CA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		2	api.fda.gov
Trinity Orthopedics, LLC	San Diego, CA, United States	Manufacturer	0		0	api.fda.gov
Tritex Medical Manufacturing LLC	Mount Morris, MI, United States	Contract manufacturer	0		0	api.fda.gov
Troy Innovative Instruments Co LLC	Middlefield, OH, United States	Contract manufacturer	0		0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	api.fda.gov
Turner Medical Inc.	Athens, AL, United States	Contract manufacturer	0		0	api.fda.gov
Tanis, Inc.	Delafield, WI, United States	Contract manufacturer	0		0	api.fda.gov
TechNH, INC.	Merrimack, NH, United States	Contract manufacturer	0		0	api.fda.gov
Tegra Medical	Hernando, MS, United States	Contract manufacturer	0		0	api.fda.gov
Tegra Medical - Dartmouth, MA	Dartmouth, MA, United States	Contract manufacturer	0		0	api.fda.gov
Tegra Medical - Franklin, MA	Franklin, MA, United States	Contract manufacturer	0		0	api.fda.gov
Teleflex LLC (NADC)	Olive Branch, MS, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Teleflex Medical LLC	Morrisville, NC, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
The E F PRECISION GROUP	Willow Grove, PA, United States	Contract manufacturer	0		0	api.fda.gov
Titan Spine, a Division of Medtronic	Milwaukee, WI, United States	Manufacturer	0		0	api.fda.gov
TranS1	Magnolia, TX, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
TriPoint Surgical	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Complaint file establishment, Contract manufacturer, Specification developer	0		0	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Ulrich Medical Usa, Inc.	Plano, TX, United States	Specification developer	0		0	api.fda.gov
Unique Surgical, LLC	Fort Wayne, IN, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Unity Tool, Inc.	Osseo, MN, United States	Contract manufacturer	0		0	api.fda.gov
Universal Punch Corp.	Santa Ana, CA, United States	Contract manufacturer	0		0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	0		0	api.fda.gov
Unified Spine, LLC	Westerville, OH, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Velco Tool & Die, Inc.	Lake Forest, CA, United States	Contract manufacturer	0		0	api.fda.gov
Vesta	Franklin, WI, United States	Contract manufacturer	0		0	api.fda.gov
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)	Parkrose, OR, United States	Contract manufacturer	0		0	api.fda.gov
Von Zabern Surgical	Riverside, CA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Vorzeigen	Connersville, IN, United States	Contract manufacturer	0		0	api.fda.gov
Vaupell Midwest Molding and Tooling	Constantine, MI, United States	Contract manufacturer	0		0	api.fda.gov
Viant AS&O Holdings, LLC	Indianapolis, IN, United States	Contract manufacturer	0		0	api.fda.gov
Viant AS&O Holdings, LLC	Brimfield, MA, United States	Contract manufacturer	0		0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	api.fda.gov
Viant San Antonio, Inc.	San Antonio, TX, United States	Contract manufacturer	0		0	api.fda.gov
Vilex LLC	Mcminnville, TN, United States	Manufacturer	0		0	api.fda.gov
West Coast Surgical LLC.	Half Moon Bay, CA, United States	Contract manufacturer	0		0	api.fda.gov
West-Conn Tool And Die Inc	Shelton, CT, United States	Contract manufacturer	0		0	api.fda.gov
Westwood Precision LLC	Allentown, PA, United States	Contract manufacturer	0		0	api.fda.gov
Wheelhouse Medical	Monroe, NC, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Wright Engineered Plastics, Inc.	Santa Rosa, CA, United States	Contract manufacturer	0		0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	0		3	api.fda.gov
West Coast Surgical LLC	Houston, TX, United States	Contract manufacturer	0		0	api.fda.gov
Winter Innovations, Inc.	Eden Prairie, MN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Xenix Medical	Orlando, FL, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Xtant Medical Holdings, Inc.	Belgrade, MT, United States	Repackager or relabeler, Specification developer	0		1	api.fda.gov
Zavation	Flowood, MS, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Zigg Design LLC	Nibley, UT, United States	Contract manufacturer	0		0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	0		25	api.fda.gov
Zsfab Inc	Waltham, MA, United States	Specification developer	0		0	api.fda.gov
Zentech Inc.	Clearwater, FL, United States	Specification developer	0		0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Contract manufacturer	0		0	api.fda.gov
b-ONE Ortho Corp.	Fairfield, NJ, United States	Specification developer	0		0	api.fda.gov
restor3d, inc.	Durham, NC, United States	Manufacturer	0		1	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.