Skip to the page

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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
JEY
Device class
2
Regulation
872.4760
Medical specialty
Dental
Implant
Yes

Makers by country

CountryMakers
United States32
Germany15
Switzerland11
South Korea9
China3
Finland2
Belgium1
Colombia1
Malaysia1
United Kingdom1
Thailand1
Ukraine1
Sweden1
Taiwan1
Brazil1
South Africa1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer43September 10, 2020020api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer36September 10, 2020000api.fda.gov
Stryker Leibinger GMBH & Co. KGFREIBURG Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer25July 12, 2024000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer, Specification developer16August 5, 2021080api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer14July 18, 2022000api.fda.gov
Bioplate, Inc.Placentia, CA, United StatesComplaint file establishment, Manufacturer, Specification developer10October 1, 2008020api.fda.gov
Jeil Medical CorporationSeoul, South KoreaManufacturer7April 2, 2026000api.fda.gov
OsteomedAddison, TX, United StatesContract manufacturer, Manufacturer7April 1, 2015000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer7December 21, 2011000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer6February 23, 2005000api.fda.gov
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer6September 18, 2001000api.fda.gov
Inion OYTAMPERE Pirkanmaa, FinlandManufacturer4November 7, 2025000api.fda.gov
Medartis AGBASEL Basel-Stadt, SwitzerlandManufacturer4September 11, 2007000api.fda.gov
Jeil Medical CorporationSiheung-si Gyeonggi, South KoreaManufacturer3April 2, 2026000api.fda.gov
Materialise N.V.LEUVEN Vlaams Brabant, BelgiumManufacturer3July 10, 2018020api.fda.gov
Materialise Colombia S.A.SMedellin Antioquia, ColombiaManufacturer3July 10, 2018000api.fda.gov
Materialise Sdn BhdPetaling Jaya Selangor, MalaysiaManufacturer3July 10, 2018000api.fda.gov
Materialise USA, LLC.Plymouth, MI, United StatesManufacturer3July 10, 2018000api.fda.gov
Osstem Implant Co., Ltd.Gangseo-gu Seoul, South KoreaSpecification developer3March 26, 2018000api.fda.gov
Osstem Implant Co., Ltd.Haeundae-gu Busan, South KoreaManufacturer3March 26, 2018000api.fda.gov
Depuy CMWBlackpool, Lancashire, United KingdomManufacturer2February 27, 2007000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer2April 13, 2011000api.fda.gov
Meticuly Co., Ltd.Bangkok Krung Thep Maha Nakhon, ThailandManufacturer2July 25, 2026000api.fda.gov
Materialise Ukraine, Rep. officeKyiv Kyyiv, Misto, UkraineManufacturer2July 10, 2018000api.fda.gov
MedCADPlano, TX, United StatesManufacturer2September 26, 2023000api.fda.gov
Osteonic Co., Ltd.Seoul, South KoreaManufacturer2October 20, 2016000api.fda.gov
SYNTHES GMBH / Synthes Produktions GmbHOberdorf, Baselland Basel-Landschaft, SwitzerlandManufacturer2February 27, 2007010api.fda.gov
VanDuzen, Inc. dba MedCADDallas, TX, United StatesManufacturer2September 26, 2023000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer2April 13, 2011000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer1May 19, 2021000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer1April 7, 2006000api.fda.gov
ARCH Medical Solutions - Escondido LLCEscondido, CA, United StatesManufacturer1September 18, 2001000api.fda.gov
Biomaterials Korea Inc.Hanam-si Gyeonggi, South KoreaManufacturer1December 8, 2011000api.fda.gov
Dentsply IH ABMOLNDAL Vastra Gotaland, SwedenSpecification developer1May 7, 1998000api.fda.gov
Impladent, Ltd.Northborough, MA, United StatesRepackager or relabeler, Specification developer1December 18, 2014000api.fda.gov
MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USANewnan, GA, United StatesManufacturer1October 11, 2018000api.fda.gov
Mci Medical Concept Innovation Inc.Sunrise, FL, United StatesManufacturer, Repackager or relabeler1December 5, 2019000api.fda.gov
Microware Precision Co., Ltd.Taichung, TaiwanContract manufacturer, Manufacturer1November 10, 2022000api.fda.gov
MegaGen Implant Co., Ltd. (Research Laboratories)Daegu, South KoreaSpecification developer1September 25, 2013000api.fda.gov
Megagen Implant Co., Ltd.Daegu, South KoreaManufacturer1September 25, 2013000api.fda.gov
Neoortho Produtos Ortopedicos S/ACuritiba Parana, BrazilContract manufacturer, Manufacturer1December 20, 2010000api.fda.gov
Osteogenics Biomedical, Inc.Lubbock, TX, United StatesManufacturer1February 4, 1999000api.fda.gov
Reoss GMBHFilderstadt Baden-Wurttemberg, GermanyManufacturer1June 17, 2020000api.fda.gov
Southern Medical (pty) LtdIRENE Gauteng, South AfricaComplaint file establishment, Exporter to the US, Manufacturer1December 19, 2025000api.fda.gov
Surgident Co., Ltd.Dong-gu Daegu, South KoreaManufacturer1May 24, 2018000api.fda.gov
Sirona Dental Systems GmbHBensheim Hesse, GermanySpecification developer1May 7, 1998000api.fda.gov
Unicare Biomedical, Inc.Laguna Hills, CA, United StatesManufacturer1August 6, 2002000api.fda.gov
Visionare LLCFort Myers, FL, United StatesComplaint file establishment, Manufacturer1December 28, 2018000api.fda.gov
Arctic Biomaterials OYTampere Pirkanmaa, FinlandContract manufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Bemotec GMBHSonnenbühl Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesContract manufacturer0020api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.Changzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Diener & Rapp GMBH & Co. KGVillingen-Schwenningen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Dot GMBHRostock Mecklenburg-Western Pomerania, GermanyContract manufacturer0000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
Dentsply Implants Manufacturing GmbHHanau Hesse, GermanyContract manufacturer0000api.fda.gov
Eptam West LLCColorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Frueh Verpackungstechnik AGFehraltorf Zurich, SwitzerlandContract manufacturer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
General Machine, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Bettlach)Bettlach Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Hagendorf)Hagendorf Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Mezzovico)Mezzovico Ticino, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Raron)Raron Valais, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Tuttlingen Manufacturing GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS Martin Manufacturing, LLCJacksonville, FL, United StatesContract manufacturer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Kontour (xi'an) Medical Technology Co., Ltd.Xi'an Shaanxi, ChinaContract manufacturer0000api.fda.gov
Kreidler Medizintechnik GmbHWurmlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Laser Integration Laser Applikation GMBHSexau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
LX Precision Shanghai Co LtdShanghai, ChinaContract manufacturer0000api.fda.gov
Maillefer Instruments Holding SarlBALLAIGUES Vaud, SwitzerlandContract manufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Quintus, Inc.Camp Verde, AZ, United StatesContract manufacturer0000api.fda.gov
Sphinx Tools LtdDerendingen Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
TecometWoburn, MA, United StatesContract manufacturer0000api.fda.gov
Wenzler Medizintechnik GmbHFrittlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.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.