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Data / Medical devices / Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented

Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented (OQH): 32 FDA-registered makers in 8 countries

32 establishments in 8 countries are registered with the FDA to make Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented (product code OQH, Class 2, 21 CFR 888.3350). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
OQH
Device class
2
Regulation
888.3350
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States23
China3
Italy1
Germany1
United Kingdom1
France1
Switzerland1
Ireland1

Makers of Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented

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
Adler Ortho S.P.A.Cormano Milano, ItalyManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
APS Materials SuzhouSuzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Biomet Uk Ltd.Bridgend, United KingdomSpecification developer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0000api.fda.gov
Centex Machining, Inc.Round Rock, TX, United StatesContract manufacturer0000api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.Changzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer0000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, 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
Medical Conteneur SASSAINT-SOUPPLETS Seine-et-Marne, FranceContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Precision Forms, Inc.Butler, NJ, United StatesContract manufacturer0000api.fda.gov
Shalby Advanced Technologies, Inc.El Dorado Hills, CA, United StatesManufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
T & L Sharpening, Inc.Indiana Beach, IN, United StatesContract manufacturer0000api.fda.gov
Zimmer GMBHWINTERTHUR Zurich, SwitzerlandContract manufacturer0000api.fda.gov
Zimmer Manufacturing B.V.Mercedita, PR, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zimmer Orthopedics Manufacturing Limited-GalwayOranmore Galway(County), IrelandContract 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.