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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer43September 10, 2020020api.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
OsteomedAddison, TX, United StatesContract manufacturer, Manufacturer7April 1, 2015000api.fda.gov
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer6September 18, 2001000api.fda.gov
Materialise USA, LLC.Plymouth, MI, United StatesManufacturer3July 10, 2018000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer2April 13, 2011000api.fda.gov
MedCADPlano, TX, United StatesManufacturer2September 26, 2023000api.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
ARCH Medical Solutions - Escondido LLCEscondido, CA, United StatesManufacturer1September 18, 2001000api.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
Osteogenics Biomedical, Inc.Lubbock, TX, United StatesManufacturer1February 4, 1999000api.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
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesContract manufacturer0020api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
Eptam West LLCColorado Springs, CO, United StatesContract 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
KLS Martin Manufacturing, LLCJacksonville, FL, United StatesContract 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
TecometWoburn, MA, United StatesContract manufacturer0000api.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.