Data / Medical devices / Orthopedic Stereotaxic Instrument / United States

FDA-registered makers of Orthopedic Stereotaxic Instrument in the United States: 222 establishments

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

222 establishments in the United States are registered with the FDA to make Orthopedic Stereotaxic Instrument (product code OLO). 79 have a 510(k) clearance or PMA approval on file and 15 have a recall event. FDA data exported November 3, 2026.

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Device: Orthopedic Stereotaxic Instrument
Product code: OLO
Country: United States

Makers of Orthopedic Stereotaxic Instrument in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Class I	Source
Mako Surgical Corp.	Weston, FL, United States	Complaint file establishment, Manufacturer, Specification developer	22	February 25, 2026	20	0	api.fda.gov
Medtronic Navigation, Inc.	Lafayette, CO, United States	Manufacturer	16	February 12, 2026	9	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	16	March 26, 2026	0	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer, Repackager or relabeler	15	February 12, 2026	1	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	15	July 18, 2023	0	0	api.fda.gov
Blue Belt Technologies, Inc.	Pittsburgh, PA, United States	Manufacturer	14	March 26, 2026	3	0	api.fda.gov
OrthAlign, Inc.	Irvine, CA, United States	Complaint file establishment, Manufacturer, Specification developer	12	June 18, 2020	1	0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	11	May 26, 2026	0	0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer	10	February 19, 2026	2	0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	10	February 19, 2026	0	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	9	April 29, 2024	0	0	api.fda.gov
K2M, Inc.	Leesburg, VA, United States	Complaint file establishment, Manufacturer, Specification developer	9	March 17, 2026	1	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	9	March 18, 2024	0	0	api.fda.gov
Think Surgical Inc.	Fremont, CA, United States	Complaint file establishment, Manufacturer, Specification developer	9	October 16, 2026	4	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	8	November 5, 2025	2	1	api.fda.gov
Nuvasive, Inc.	San Diego, CA, United States	Complaint file establishment, Manufacturer, Specification developer	8	August 2, 2024	1	0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	7	April 5, 2024	0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	7	April 24, 2018	2	0	api.fda.gov
Stryker Instruments	Portage, MI, United States	Complaint file establishment, Specification developer	7	February 19, 2026	0	0	api.fda.gov
Nuvasive, Inc.	Guaynabo, PR, United States	Manufacturer	6	August 2, 2024	0	0	api.fda.gov
Alphatec Spine, Inc.	Louisville, CO, United States	Specification developer	5	February 19, 2026	0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	5	June 25, 2026	1	0	api.fda.gov
Smith & Nephew Inc.	Mansfield, MA, United States	Manufacturer	5	March 26, 2026	0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	5	November 3, 2021	0	0	api.fda.gov
Zavation	Flowood, MS, United States	Complaint file establishment, Manufacturer, Specification developer	5	May 2, 2023	0	0	api.fda.gov
DePuy Synthes West Palm Beach	West Palm Beach, FL, United States	Manufacturer	4	June 14, 2024	0	0	api.fda.gov
Globus Medical, Inc.	Methuen, MA, United States	Manufacturer	4	August 25, 2021	0	0	api.fda.gov
Medtronic Powered Surgical Solutions	Fort Worth, TX, United States	Manufacturer	4	February 12, 2026	0	0	api.fda.gov
OMNIlife science, Inc.	Milpitas, CA, United States	Specification developer	4	July 26, 2023	0	0	api.fda.gov
OMNIlifeScience, Inc.	Raynham, MA, United States	Manufacturer	4	July 26, 2023	2	0	api.fda.gov
Proprio	Seattle, WA, United States	Complaint file establishment, Specification developer	4	December 15, 2025	0	0	api.fda.gov
Si-Bone, Inc.	Santa Clara, CA, United States	Complaint file establishment, Specification developer	4	September 15, 2025	0	0	api.fda.gov
Si-Bone, Inc.	Santa Clara, CA, United States	Manufacturer, Specification developer	4	September 15, 2025	0	0	api.fda.gov
The Anspach Effort, Inc.	Palm Bch Gdns, FL, United States	Manufacturer	4	June 14, 2024	0	0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer	4	May 26, 2023	0	0	api.fda.gov
Astura Medical	Irving, TX, United States	Complaint file establishment, Specification developer	3	October 17, 2024	0	0	api.fda.gov
Choice Spine LLC	Knoxville, TN, United States	Complaint file establishment, Specification developer	3	July 6, 2022	0	0	api.fda.gov
INNO Holdings Inc.	Millcreek, UT, United States	Manufacturer	3	July 23, 2025	0	0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Complaint file establishment, Manufacturer	3	October 31, 2025	0	0	api.fda.gov
Providence Medical Technology, Inc.	Pleasanton, CA, United States	Complaint file establishment, Manufacturer, Specification developer	3	June 18, 2026	0	0	api.fda.gov
Precision Spine, Inc.	Pearl, MS, United States	Manufacturer	3	May 25, 2023	0	0	api.fda.gov
Spine Wave, Inc.	Shelton, CT, United States	Manufacturer, Specification developer	3	April 3, 2025	0	0	api.fda.gov
Spineology Inc.	Saint Paul, MN, United States	Manufacturer	3	December 4, 2025	0	0	api.fda.gov
Stryker Spine	Allendale, NJ, United States	Complaint file establishment, Manufacturer, Specification developer	3	May 17, 2019	0	0	api.fda.gov
Surgentec LLC	Boca Raton, FL, United States	Manufacturer	3	July 24, 2026	0	0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	3	March 29, 2023	0	0	api.fda.gov
Degen Medical	Florence, SC, United States	Complaint file establishment, Specification developer	2	February 9, 2022	0	0	api.fda.gov
JMG Machine, Inc.	La Mirada, CA, United States	Contract manufacturer, Manufacturer	2	June 6, 2012	0	0	api.fda.gov
Life Spine	Huntley, IL, United States	Specification developer	2	June 2, 2026	0	0	api.fda.gov
Mirus, LLC	Marietta, GA, United States	Manufacturer	2	March 18, 2026	0	0	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	2	May 29, 2026	0	0	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	2	May 29, 2026	0	0	api.fda.gov
Ulrich Medical Usa, Inc.	Plano, TX, United States	Specification developer	2	February 3, 2026	0	0	api.fda.gov
Altus Partners	West Chester, PA, United States	Specification developer	1	May 8, 2025	0	0	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Contract manufacturer, Repackager or relabeler	1	March 14, 2025	0	0	api.fda.gov
Camber Spine Technologies	King of Prussia, PA, United States	Complaint file establishment, Specification developer	1	April 29, 2022	0	0	api.fda.gov
CTL Medical Corporation	Carrollton, TX, United States	Complaint file establishment, Manufacturer, Specification developer	1	May 12, 2022	0	0	api.fda.gov
Curiteva, Inc.	Tanner, AL, United States	Contract manufacturer, Manufacturer	1	January 6, 2023	0	0	api.fda.gov
Evolution Spine, LLC	Dallas, TX, United States	Complaint file establishment, Manufacturer, Specification developer	1	August 18, 2025	0	0	api.fda.gov
Foundation Surgical Group	Scottsdale, AZ, United States	Specification developer	1	April 16, 2026	0	0	api.fda.gov
Genesys Spine	Austin, TX, United States	Manufacturer	1	March 29, 2024	0	0	api.fda.gov
Isotis Orthobiologics, Inc	Irvine, CA, United States	Complaint file establishment, Manufacturer, Specification developer	1	April 2, 2025	0	0	api.fda.gov
Izi Medical Products LLC	Owings Mills, MD, United States	Manufacturer	1	August 7, 2019	0	0	api.fda.gov
Kalitec Direct LLC DBA Kalitec Medical	Sarasota, FL, United States	Complaint file establishment, Specification developer	1	December 13, 2023	0	0	api.fda.gov
Medivis, Inc.	New York, NY, United States	Manufacturer	1	July 26, 2024	0	0	api.fda.gov
Microport Navibot International LLC	Arlington, TN, United States	Manufacturer	1	July 7, 2022	0	0	api.fda.gov
Medtronic Grand Rapids	Grand Rapids, MI, United States	Manufacturer	1	August 14, 2013	0	0	api.fda.gov
Nexxt Spine LLC	Noblesville, IN, United States	Complaint file establishment, Manufacturer	1	March 31, 2022	0	0	api.fda.gov
Novarad Corp.	Provo, UT, United States	Manufacturer	1	May 27, 2022	0	0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	1	February 4, 2021	0	0	api.fda.gov
Osseus Fusion Systems LLC	Dallas, TX, United States	Repackager or relabeler, Specification developer	1	January 17, 2020	0	0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	1	December 23, 2021	0	0	api.fda.gov
OsteoCentric Technologies,Inc	Logan, UT, United States	Complaint file establishment, Specification developer	1	October 27, 2025	0	0	api.fda.gov
Promethean Restorative Inc.	Castle Rock, CO, United States	Complaint file establishment, Specification developer	1	January 12, 2026	0	0	api.fda.gov
Republic Spine	Fort Lauderdale, FL, United States	Complaint file establishment, Manufacturer	1	September 27, 2021	0	0	api.fda.gov
Seaspine Orthopedics Corporation	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	1	May 11, 2018	1	0	api.fda.gov
Smith & Nephew Inc.	Andover, MA, United States	Specification developer	1	November 14, 2011	0	0	api.fda.gov
Spinal Elements, Inc.	Carlsbad, CA, United States	Complaint file establishment, Manufacturer	1	December 19, 2019	0	0	api.fda.gov
Spinecraft LLC	Westmont, IL, United States	Manufacturer, Specification developer	1	July 20, 2023	0	0	api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)	Riviera Beach, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
Alden Tool Company, Inc.	Berlin, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
All Quality & Services, Inc.	Fremont, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
All Quality & Services, Inc.	Garland, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
American Manufacturing And Engineering	Montgomeryville, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH - Quakertown	Quakertown, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical Components	Huntingdon Valley, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Elmhurst	Elmhurst, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Olive Branch	Olive Branch, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH-MedTorque	Kenosha, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Autocam Medical	Kentwood, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Axial Medical	Ivyland, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
B & G MFG. Co.	Hatfield, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
B & J Medical LLC	Kendallville, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Benchmark Electronics, Inc.	Winona, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Benchmark Electronics, Inc.	Rochester, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Branch Medical Group	Eagleville, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Branch Medical Group	Limerick, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
C&A Tool Engineering, Inc. Auburn Plant	Auburn, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
C&W Swiss, Inc.	Clayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Classic Wire Cut Company, Inc.	Valencia, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Cadence Inc.	Staunton, VA, United States	Contract manufacturer	0		0	0	api.fda.gov
Cicor Ohio, Solon	Solon, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Elite Medical, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Elite Medical, LLC	Florence, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Elite Medical, LLC	Cordova, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Ferry Machine Corporation	Oakland, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
First Article Inc	Souderton, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Flex-Cell Precision, Inc.	Lancaster, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Ferry Machine Corporation	Little Ferry, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Guardian Medical Usa, Inc	Swanton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Harwood Design, Inc.	Bristol, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Hirsh Precision Products	Frederick, CO, United States	Contract manufacturer	0		0	0	api.fda.gov
Illuminant Surgical, Inc.	Los Angeles, CA, United States	Manufacturer for export	0		0	0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Insert Molding Solutions, Inc.	Cumming, GA, United States	Contract manufacturer	0		0	0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Integra Lifesciences Corporation	Cincinnati, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Instrumed International Inc dba Avalign German Specialty Instruments	Schaumburg, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
IntriCon Corporation Grey Fox	Arden Hills, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
J & J Precision Technologies, LLC	Lititz, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
J&B Precision, Inc.	Cordova, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Jatex, Inc.	Nappanee, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	0	api.fda.gov
Lacey Manufacturing Company LLC	Bridgeport, CT, United States	Manufacturer	0		0	0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Life Science Outsourcing, Inc.	Brea, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Linemaster Switch Corp.	Woodstock, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
Lowell,inc.	Brooklyn Park, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Mach Medical	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Mackay Manufacturing, Inc.	Spokane Valley, WA, United States	Contract manufacturer	0		0	0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Medtronic Puerto Rico Operations Co., Humacao	Humacao, PR, United States	Manufacturer	0		0	0	api.fda.gov
Medtronic Puerto Rico Operations Co., Juncos	Juncos, PR, United States	Manufacturer	0		0	0	api.fda.gov
Micro Precision Swiss	Santa Ana, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Midwest Products And Engineering	Milwaukee, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Minnetronix, Inc.	Saint Paul, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Monogram Technologies, LLC	Austin, TX, United States	Manufacturer for export	0		0	0	api.fda.gov
Mount MFG	Marquette, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Multisource Manufacturing LLC	Longmont, CO, United States	Contract manufacturer	0		0	0	api.fda.gov
Multisource Manufacturing LLC	Ramsey, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Microcision LLC	Pennsauken, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Miller Technical Services	Plymouth, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
Ngage Medical Manufacturing	Hernando, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Nview Medical	Salt Lake City, UT, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
NextPhase Medical Devices LLC	Rochester, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Oberg Medical Products Company	Sarver, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Pacific Instruments Inc.	Honolulu, HI, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
PMC SMART Solutions, LLC	Shelbyville, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Precipart Corp	Farmingdale, NY, United States	Contract manufacturer	0		0	0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Precision Medical Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Precision Medical Technologies	Rome City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Preferred Depot	Irvine, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Pro-Dex, Inc.	Irvine, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Prospect Life Sciences	Westminster, CO, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Pioneer Surgical Technology, Inc.	Marquette, MI, United States	Contract manufacturer	0		3	0	api.fda.gov
Precision Edge Surgical Products, LLC	Angola, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing Facility	N Manchester, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Pro-Dex Inc	Tustin, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
R.H. Cross Enterprises, Inc.	Portage, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Remington Medical, Inc.	Alpharetta, GA, United States	Contract manufacturer	0		0	0	api.fda.gov
RMS Co.	Minneapolis, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Remington Medical, Inc.	Alpharetta, GA, United States	Contract manufacturer	0		0	0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Stoll Metalcraft, Inc.	Santa Clarita, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Structure Medical, LLC.	Naples, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
Stryker Manufacturing Kalamazoo	Portage, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Spartronics Watertown LLC	Watertown, SD, United States	Contract manufacturer	0		0	0	api.fda.gov
Structure Medical, LLC.	Mooresville, NC, United States	Contract manufacturer	0		0	0	api.fda.gov
SunMed Group Holdings, LLC	Grand Rapids, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Teslake, Inc.	San Diego, CA, United States	Specification developer	0		0	0	api.fda.gov
Trigon America LLC	Aurora, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
Turner Medical Inc.	Athens, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Tegra Medical	Hernando, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
Titan Spine, a Division of Medtronic	Milwaukee, WI, United States	Manufacturer	0		0	0	api.fda.gov
Trelleborg Sealing Solutions Litchfield	Litchfield, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Victoria Precision Inc.	Trevose, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)	Parkrose, OR, United States	Contract manufacturer	0		0	0	api.fda.gov
Vorzeigen	Connersville, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant AS&O Holdings, LLC	Laconia, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant Medical, Inc.	Grand Rapids, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant San Antonio, Inc.	San Antonio, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant Upland, Inc	Upland, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
West-Conn Tool And Die Inc	Shelton, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
Westwood Precision LLC	Allentown, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Xenix Medical	Orlando, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	0	api.fda.gov

Updated November 3, 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.