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Data / Medical devices / Prosthesis, Elbow, Constrained, Cemented / United States

FDA-registered makers of Prosthesis, Elbow, Constrained, Cemented in the United States: 32 establishments

32 establishments in the United States are registered with the FDA to make Prosthesis, Elbow, Constrained, Cemented (product code JDC). 8 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Prosthesis, Elbow, Constrained, Cemented
Product code
JDC
Country
United States

Makers of Prosthesis, Elbow, Constrained, Cemented in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer8January 28, 2019070api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer3February 3, 2016040api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer3March 25, 2009000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer2April 14, 2006000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer2April 14, 2006000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer1October 9, 1990000api.fda.gov
Howmedica Osteonics CorpMahwah, NJ, United StatesManufacturer1May 5, 1998010api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1October 9, 1990000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
Centex Machining, Inc.Round Rock, TX, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Dot America, Inc.Columbia City, IN, United StatesContract manufacturer0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer0000api.fda.gov
Ken-Mar Machine MFG CorpPaterson, NJ, United StatesContract manufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Oberg Medical Products CompanySarver, PA, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Precision Forms, Inc.Butler, NJ, United StatesContract manufacturer0000api.fda.gov
Phillips Precision IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
SCT, Inc.Franklin Lakes, NJ, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, 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.