Data / Medical devices / Plate, Bone / United States
FDA-registered makers of Plate, Bone in the United States: 32 establishments
32 establishments in the United States are registered with the FDA to make Plate, Bone (product code JEY). 19 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Plate, Bone
- Product code
- JEY
- Country
- United States
Makers of Plate, Bone in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 43 | September 10, 2020 | 0 | 2 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer, Specification developer | 16 | August 5, 2021 | 0 | 8 | 0 | api.fda.gov |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 14 | July 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Bioplate, Inc. | Placentia, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 10 | October 1, 2008 | 0 | 2 | 0 | api.fda.gov |
| Osteomed | Addison, TX, United States | Contract manufacturer, Manufacturer | 7 | April 1, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Neurosurgery | Fort Worth, TX, United States | Specification developer | 6 | September 18, 2001 | 0 | 0 | 0 | api.fda.gov |
| Materialise USA, LLC. | Plymouth, MI, United States | Manufacturer | 3 | July 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 2 | April 13, 2011 | 0 | 0 | 0 | api.fda.gov |
| MedCAD | Plano, TX, United States | Manufacturer | 2 | September 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| VanDuzen, Inc. dba MedCAD | Dallas, TX, United States | Manufacturer | 2 | September 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer | 2 | April 13, 2011 | 0 | 0 | 0 | api.fda.gov |
| Acumed LLC | Hillsboro, OR, United States | Manufacturer | 1 | May 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| ARCH Medical Solutions - Escondido LLC | Escondido, CA, United States | Manufacturer | 1 | September 18, 2001 | 0 | 0 | 0 | api.fda.gov |
| Impladent, Ltd. | Northborough, MA, United States | Repackager or relabeler, Specification developer | 1 | December 18, 2014 | 0 | 0 | 0 | api.fda.gov |
| MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA | Newnan, GA, United States | Manufacturer | 1 | October 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Mci Medical Concept Innovation Inc. | Sunrise, FL, United States | Manufacturer, Repackager or relabeler | 1 | December 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Osteogenics Biomedical, Inc. | Lubbock, TX, United States | Manufacturer | 1 | February 4, 1999 | 0 | 0 | 0 | api.fda.gov |
| Unicare Biomedical, Inc. | Laguna Hills, CA, United States | Manufacturer | 1 | August 6, 2002 | 0 | 0 | 0 | api.fda.gov |
| Visionare LLC | Fort Myers, FL, United States | Complaint file establishment, Manufacturer | 1 | December 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| DSM Biomedical, Inc. | Exton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam West LLC | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| General Machine, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Brandywine) | W Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Elmira) | Horseheads, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin Manufacturing, LLC | Jacksonville, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quintus, Inc. | Camp Verde, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecomet | Woburn, MA, United States | Contract manufacturer | 0 | 0 | 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.