Data / Medical devices / Template / United States

FDA-registered makers of Template in the United States: 222 establishments

Name: FDA-registered makers of Template 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 Template (product code HWT). 0 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device: Template
Product code: HWT
Country: United States

Makers of Template in the United States

Maker	Location	Role	Recall events	Source
3Spine, Inc.	Chattanooga, TN, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0	api.fda.gov
4web Inc.	Frisco, TX, United States	Specification developer	0	api.fda.gov
Acumed LLC	Hillsboro, OR, United States	Manufacturer	0	api.fda.gov
Allergan Sales, LLC	Irvine, CA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer	0	api.fda.gov
Apex Resource Technologies, Inc., PPC Industries, A Spectrum Plastics Group Co.	Pittsfield, MA, United States	Contract manufacturer	0	api.fda.gov
Aptis Medical, LLC.	Glenview, KY, United States	Manufacturer	0	api.fda.gov
ARCH - Quakertown	Quakertown, PA, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	0	api.fda.gov
Autocam Medical	Kentwood, MI, United States	Contract manufacturer	0	api.fda.gov
AVALIGN TECHNOLOGIES, Inc.	Fort Wayne, IN, United States	Specification developer	0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer	0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, United States	Contract manufacturer	0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0	api.fda.gov
B-One Ortho, Corp.	Cedar Knolls, NJ, United States	Manufacturer	0	api.fda.gov
Banister Tool, Inc.	Pflugerville, TX, United States	Contract manufacturer	0	api.fda.gov
Biogennix, LLC	Irvine, CA, United States	Specification developer	0	api.fda.gov
Biomet Microfixation	Jacksonville, FL, United States	Manufacturer, Specification developer	1	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	3	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Contract manufacturer	0	api.fda.gov
Bioseal	Placentia, CA, United States	Contract manufacturer	0	api.fda.gov
Blustone Synergy, LLC	Pueblo, CO, United States	Specification developer	0	api.fda.gov
Boedeker Plastics, Inc.	Shiner, TX, United States	Contract manufacturer	0	api.fda.gov
BioDynamik	Lake Forest, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
C&W Swiss, Inc.	Clayton, OH, United States	Contract manufacturer	0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0	api.fda.gov
Caira Surgical Corporation	New York, NY, United States	Specification developer	0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer	0	api.fda.gov
Circumfix Solutions, Inc	Collierville, TN, United States	Specification developer	0	api.fda.gov
Cole Instruments	Alpharetta, GA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Cook Biotech, Inc.	West Lafayette, IN, United States	Manufacturer	0	api.fda.gov
Crossroads Extremity Systems LLC	Memphis, TN, United States	Manufacturer	0	api.fda.gov
CTL Medical Corporation	Carrollton, TX, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0	api.fda.gov
Catts Inc.	Fort Wayne, IN, United States	Contract manufacturer	0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	3	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	0	api.fda.gov
Eca Medical Instruments	Newbury Park, CA, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Elevation Spine	Monterey, CA, United States	Specification developer	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	1	api.fda.gov
Eptam Plastics, Ltd	Northfield, NH, United States	Contract manufacturer	0	api.fda.gov
Eptam West LLC	Colorado Springs, CO, United States	Contract manufacturer	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Elite Medical, LLC	Bartlett, TN, United States	Contract manufacturer	0	api.fda.gov
Elite Medical, LLC	Florence, AL, United States	Contract manufacturer	0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0	api.fda.gov
Extremity Medical, LLC	Parsippany, NJ, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0	api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower	Horsham, PA, United States	Specification developer	0	api.fda.gov
Fusion Orthopedics Usa, LLC	Mesa, AZ, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0	api.fda.gov
Genesys Spine	Austin, TX, United States	Manufacturer	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0	api.fda.gov
GLW, Inc.	Englewood Cliffs, NJ, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Gramercy Extremity Orthopedics, LLC.	Richardson, TX, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Gsource, LLC.	Emerson, NJ, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Holmed LLC	Attleboro, MA, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Manufacturer, Specification developer	2	api.fda.gov
Haven Manufacturing	Ossian, IN, United States	Contract manufacturer	0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	0	api.fda.gov
Impact Printing And Design	Columbus, OH, United States	Contract manufacturer	0	api.fda.gov
In2bones Usa, LLC	Cordova, TN, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer	0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Instrumed International Inc dba Avalign German Specialty Instruments	Schaumburg, IL, United States	Contract manufacturer, Repackager or relabeler	0	api.fda.gov
Integra LifeSciences Production Corporation	Mansfield, MA, United States	Specification developer	0	api.fda.gov
Intrinsic Therapeutics, Inc.	Woburn, MA, United States	Manufacturer	0	api.fda.gov
J&B Precision, Inc.	Cordova, TN, United States	Contract manufacturer	0	api.fda.gov
Jatex, Inc.	Nappanee, IN, United States	Contract manufacturer	0	api.fda.gov
JMG Machine, Inc.	La Mirada, CA, United States	Contract manufacturer	0	api.fda.gov
Jabil Inc. (Brandywine)	W Chester, PA, United States	Contract manufacturer	0	api.fda.gov
Jabil Inc. (Elmira)	Horseheads, NY, United States	Contract manufacturer	0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0	api.fda.gov
K2M, Inc.	Leesburg, VA, United States	Manufacturer, Specification developer	0	api.fda.gov
Kapp Surgical, Inc.	Cleveland, OH, United States	Manufacturer	0	api.fda.gov
Kapstone Manufacturing	Charlotte, NC, United States	Contract manufacturer	0	api.fda.gov
KLS Martin Manufacturing, LLC	Jacksonville, FL, United States	Contract manufacturer	0	api.fda.gov
KLS-Martin L.P.	Jacksonville, FL, United States	Specification developer	0	api.fda.gov
Kalitec Direct LLC DBA Kalitec Medical	Sarasota, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Lento Medical Innovation, Inc.	Houston, TX, United States	Manufacturer for export	0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Contract manufacturer	0	api.fda.gov
LinkBio Corp.	Dover, NJ, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer	0	api.fda.gov
Longeviti Neuro Solutions	Baltimore, MD, United States	Manufacturer	0	api.fda.gov
Mack Molding Company	Arlington, VT, United States	Contract manufacturer	0	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Manufacturer	0	api.fda.gov
Medical Modeling - A 3D Systems Company	Littleton, CO, United States	Manufacturer	0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Specification developer	0	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0	api.fda.gov
Medtronic Puerto Rico Operations Co., Humacao	Humacao, PR, United States	Manufacturer	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	0	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0	api.fda.gov
Millennium Surgical Corp	Schaumburg, IL, United States	Contract manufacturer, Repackager or relabeler	0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0	api.fda.gov
Moximed, Inc.	Fremont, CA, United States	Manufacturer	0	api.fda.gov
Mack Proto	Gardner, MA, United States	Contract manufacturer	0	api.fda.gov
Masterbilt Incorporated	South Bend, IN, United States	Contract manufacturer	0	api.fda.gov
Materialise USA, LLC.	Plymouth, MI, United States	Manufacturer	1	api.fda.gov
Mendell	Lakeville, MN, United States	Contract manufacturer	0	api.fda.gov
Merge Healthcare Incorporated	Hartland, WI, United States	Manufacturer	0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0	api.fda.gov
Nexus CMF	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Nexus Spine, L.L.C.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Nexus Spine, LLC.	Lehi, UT, United States	Specification developer	0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0	api.fda.gov
Nuvasive, Inc.	San Diego, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
NuVasive Specialized Orthopedics, Inc.	Audubon, PA, United States	Manufacturer	0	api.fda.gov
Oberg Medical Products Company	Sarver, PA, United States	Contract manufacturer	0	api.fda.gov
Omega Plastics, Inc.	Clinton Township, MI, United States	Contract manufacturer	0	api.fda.gov
Onkos Surgical, Inc.	Parsippany, NJ, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Orchid Orthopedic Solutions Oregon, Inc.	Oregon City, OR, United States	Contract manufacturer	0	api.fda.gov
Orchid Orthopedics-Chelsea	Chelsea, MI, United States	Contract manufacturer	0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Manufacturer	0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Osteomed	Addison, TX, United States	Manufacturer, Specification developer	0	api.fda.gov
Osteoremedies, LLC	Memphis, TN, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Overture Orthopaedics	Irvine, CA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, United States	Contract manufacturer	0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0	api.fda.gov
OrthAlign, Inc.	Irvine, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Orthopedic Designs North America, Inc.	Tampa, FL, United States	Manufacturer	0	api.fda.gov
Pacific Instruments Inc.	Honolulu, HI, United States	Contract manufacturer	0	api.fda.gov
Paragon 28	Englewood, CO, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0	api.fda.gov
Perryman Company	Houston, PA, United States	Contract manufacturer	0	api.fda.gov
Poriferous, LLC	Newnan, GA, United States	Manufacturer	0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0	api.fda.gov
Paragon Medical Inc.	Castleton, IN, United States	Contract manufacturer	0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0	api.fda.gov
Pioneer Surgical Technology, Inc.	Marquette, MI, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing Facility	N Manchester, IN, United States	Contract manufacturer	0	api.fda.gov
Precision Spine, Inc.	Pearl, MS, United States	Manufacturer	0	api.fda.gov
ProMed Concepts, LLC	Brighton, TN, United States	Contract manufacturer	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Red Star Contract Manufacturing Inc.	Larwill, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0	api.fda.gov
S. Jackson, Inc.	Alexandria, VA, United States	Manufacturer	0	api.fda.gov
Scotty Medical, LLC	New York, NY, United States	Manufacturer	0	api.fda.gov
Seaspine Orthopedics Corporation	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	0	api.fda.gov
SIGN Fracture Care International	Richland, WA, United States	Manufacturer	0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0	api.fda.gov
Sky Surgical	Parkville, MO, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0	api.fda.gov
Smith & Nephew Inc.	Andover, MA, United States	Specification developer	0	api.fda.gov
Smith & Nephew Inc.	Mansfield, MA, United States	Manufacturer	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Spine Wave, Inc.	Shelton, CT, United States	Manufacturer, Specification developer	0	api.fda.gov
Structure Medical, LLC.	Naples, FL, United States	Contract manufacturer	0	api.fda.gov
Stryker Spine	Allendale, NJ, United States	Manufacturer, Specification developer	0	api.fda.gov
Summit MFG. And Machining, Inc.	Bremen, IN, United States	Contract manufacturer	0	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Lansing, MI, United States	Contract manufacturer	0	api.fda.gov
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0	api.fda.gov
Tech-Etch, Inc.	Plymouth, MA, United States	Contract manufacturer	0	api.fda.gov
Tecomet	Woburn, MA, United States	Contract manufacturer	0	api.fda.gov
Tecomet, Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0	api.fda.gov
Theken Companies, LLC	Akron, OH, United States	Specification developer	0	api.fda.gov
TOMZ Corporation	Berlin, CT, United States	Contract manufacturer	0	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	Specification developer	0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Treace Medical Concepts, Inc.	Ponte Vedra, FL, United States	Manufacturer	0	api.fda.gov
Trigon America LLC	Aurora, IL, United States	Contract manufacturer	0	api.fda.gov
Trimed, Inc.	Santa Clarita, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0	api.fda.gov
Turner Medical Inc.	Athens, AL, United States	Contract manufacturer	0	api.fda.gov
Teleflex LLC (NADC)	Olive Branch, MS, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Titan Spine, a Division of Medtronic	Milwaukee, WI, United States	Manufacturer	0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0	api.fda.gov
Unity Tool, Inc.	Osseo, MN, United States	Contract manufacturer	0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	0	api.fda.gov
Visionare LLC	Fort Myers, FL, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
VanDuzen, Inc. dba MedCAD	Dallas, TX, United States	Manufacturer	0	api.fda.gov
Viant AS&O Holdings, LLC	Brimfield, MA, United States	Contract manufacturer	0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Contract manufacturer	0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
West-Conn Tool And Die Inc	Shelton, CT, United States	Contract manufacturer	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Specification developer	0	api.fda.gov
Xenix Medical	Orlando, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Xtant Medical Holdings, Inc.	Belgrade, MT, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Zien Medical Technologies LLC	Salt Lake City, UT, United States	Contract manufacturer	0	api.fda.gov
Zigg Design LLC	Nibley, UT, United States	Contract manufacturer	0	api.fda.gov
Zimmer Manufacturing B.V.	Mercedita, PR, United States	Manufacturer	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	7	api.fda.gov
ZimVie US Corp LLC	Palm Beach Gardens, FL, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	0	api.fda.gov
b-ONE Ortho Corp.	Fairfield, NJ, United States	Specification developer	0	api.fda.gov
restor3d, inc.	Durham, NC, United States	Manufacturer	0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	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.