Data / Medical devices / Plate, Bone
Plate, Bone (JEY): 82 FDA-registered makers in 16 countries
82 establishments in 16 countries are registered with the FDA to make Plate, Bone (product code JEY, Class 2, 21 CFR 872.4760). 48 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 294 510(k) clearances under this code, the latest on August 17, 2026, and lists 23 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JEY
- Device class
- 2
- Regulation
- 872.4760
- Medical specialty
- Dental
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 32 |
| Germany | 15 |
| Switzerland | 11 |
| South Korea | 9 |
| China | 3 |
| Finland | 2 |
| Belgium | 1 |
| Colombia | 1 |
| Malaysia | 1 |
| United Kingdom | 1 |
| Thailand | 1 |
| Ukraine | 1 |
| Sweden | 1 |
| Taiwan | 1 |
| Brazil | 1 |
| South Africa | 1 |
Makers of Plate, Bone
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 36 | September 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Stryker Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 25 | July 12, 2024 | 0 | 0 | 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 |
| Jeil Medical Corporation | Seoul, South Korea | Manufacturer | 7 | April 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Osteomed | Addison, TX, United States | Contract manufacturer, Manufacturer | 7 | April 1, 2015 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 7 | December 21, 2011 | 0 | 0 | 0 | api.fda.gov |
| Medicon, E.G. | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 6 | February 23, 2005 | 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 |
| Inion OY | TAMPERE Pirkanmaa, Finland | Manufacturer | 4 | November 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medartis AG | BASEL Basel-Stadt, Switzerland | Manufacturer | 4 | September 11, 2007 | 0 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Siheung-si Gyeonggi, South Korea | Manufacturer | 3 | April 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Materialise N.V. | LEUVEN Vlaams Brabant, Belgium | Manufacturer | 3 | July 10, 2018 | 0 | 2 | 0 | api.fda.gov |
| Materialise Colombia S.A.S | Medellin Antioquia, Colombia | Manufacturer | 3 | July 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Materialise Sdn Bhd | Petaling Jaya Selangor, Malaysia | Manufacturer | 3 | July 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Materialise USA, LLC. | Plymouth, MI, United States | Manufacturer | 3 | July 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 3 | March 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Haeundae-gu Busan, South Korea | Manufacturer | 3 | March 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Depuy CMW | Blackpool, Lancashire, United Kingdom | Manufacturer | 2 | February 27, 2007 | 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 |
| Meticuly Co., Ltd. | Bangkok Krung Thep Maha Nakhon, Thailand | Manufacturer | 2 | July 25, 2026 | 0 | 0 | 0 | api.fda.gov |
| Materialise Ukraine, Rep. office | Kyiv Kyyiv, Misto, Ukraine | Manufacturer | 2 | July 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| MedCAD | Plano, TX, United States | Manufacturer | 2 | September 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| Osteonic Co., Ltd. | Seoul, South Korea | Manufacturer | 2 | October 20, 2016 | 0 | 0 | 0 | api.fda.gov |
| SYNTHES GMBH / Synthes Produktions GmbH | Oberdorf, Baselland Basel-Landschaft, Switzerland | Manufacturer | 2 | February 27, 2007 | 0 | 1 | 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 |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 1 | April 7, 2006 | 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 |
| Biomaterials Korea Inc. | Hanam-si Gyeonggi, South Korea | Manufacturer | 1 | December 8, 2011 | 0 | 0 | 0 | api.fda.gov |
| Dentsply IH AB | MOLNDAL Vastra Gotaland, Sweden | Specification developer | 1 | May 7, 1998 | 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 |
| Microware Precision Co., Ltd. | Taichung, Taiwan | Contract manufacturer, Manufacturer | 1 | November 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| MegaGen Implant Co., Ltd. (Research Laboratories) | Daegu, South Korea | Specification developer | 1 | September 25, 2013 | 0 | 0 | 0 | api.fda.gov |
| Megagen Implant Co., Ltd. | Daegu, South Korea | Manufacturer | 1 | September 25, 2013 | 0 | 0 | 0 | api.fda.gov |
| Neoortho Produtos Ortopedicos S/A | Curitiba Parana, Brazil | Contract manufacturer, Manufacturer | 1 | December 20, 2010 | 0 | 0 | 0 | api.fda.gov |
| Osteogenics Biomedical, Inc. | Lubbock, TX, United States | Manufacturer | 1 | February 4, 1999 | 0 | 0 | 0 | api.fda.gov |
| Reoss GMBH | Filderstadt Baden-Wurttemberg, Germany | Manufacturer | 1 | June 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Southern Medical (pty) Ltd | IRENE Gauteng, South Africa | Complaint file establishment, Exporter to the US, Manufacturer | 1 | December 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Surgident Co., Ltd. | Dong-gu Daegu, South Korea | Manufacturer | 1 | May 24, 2018 | 0 | 0 | 0 | api.fda.gov |
| Sirona Dental Systems GmbH | Bensheim Hesse, Germany | Specification developer | 1 | May 7, 1998 | 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 |
| Arctic Biomaterials OY | Tampere Pirkanmaa, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bemotec GMBH | Sonnenbühl Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diener & Rapp GMBH & Co. KG | Villingen-Schwenningen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dot GMBH | Rostock Mecklenburg-Western Pomerania, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DSM Biomedical, Inc. | Exton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply Implants Manufacturing GmbH | Hanau Hesse, Germany | 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 | |
| Frueh Verpackungstechnik AG | Fehraltorf Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gebr. Brasseler GMBH & Co. KG | LEMGO North Rhine-Westphalia, Germany | 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 | |
| Jabil Switzerland Manufacturing GmbH (Bettlach) | Bettlach Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Hagendorf) | Hagendorf Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Mezzovico) | Mezzovico Ticino, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Raron) | Raron Valais, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Tuttlingen Manufacturing GmbH | Tuttlingen Baden-Wurttemberg, Germany | 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 | |
| KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kontour (xi'an) Medical Technology Co., Ltd. | Xi'an Shaanxi, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kreidler Medizintechnik GmbH | Wurmlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laser Integration Laser Applikation GMBH | Sexau Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LX Precision Shanghai Co Ltd | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maillefer Instruments Holding Sarl | BALLAIGUES Vaud, Switzerland | 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 | |
| Sphinx Tools Ltd | Derendingen Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecomet | Woburn, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzler Medizintechnik GmbH | Frittlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 17, 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.