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Data / Medical devices / Orthopedic Tray

Orthopedic Tray (OJH): 43 FDA-registered makers in 14 countries

43 establishments in 14 countries are registered with the FDA to make Orthopedic Tray (product code OJH, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 87 recall events (11 Class I). FDA data exported November 2, 2026.

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Product code
OJH
Device class
1
Regulation
878.4800
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States23
Mexico4
Australia2
Taiwan2
United Kingdom2
Switzerland2
Malaysia1
Dominican Republic1
China1
Italy1
Honduras1
Finland1
Israel1
France1

Makers of Orthopedic Tray

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
3D Instrumentation Sdn BhdBukit Mertajam Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer0000api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler0041api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesSpecification developer0000api.fda.gov
Cardinal Health 200, LLCEl Paso, TX, United StatesManufacturer0000api.fda.gov
Convertors de Mexico S. de R.L. de C.VCD.JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
Eca Medical InstrumentsNewbury Park, CA, United StatesContract manufacturer0000api.fda.gov
Embody, Inc.Norfolk, VA, United StatesManufacturer0000api.fda.gov
Field OrthopaedicsTeneriffe Queensland, AustraliaSpecification developer0000api.fda.gov
Global Resources International Dominicana Grid S.R.L.San Pedro de Macoris, Dominican RepublicContract manufacturer0000api.fda.gov
Gri Medical & Electronic Technology Co., Ltd.JIAXING Zhejiang, ChinaManufacturer0000api.fda.gov
GRI-Alleset, Inc.Flowery Branch, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
HPF S.R.L.Forgaria nel Friuli Friuli Venezia Giulia, ItalyManufacturer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Inion OYTAMPERE Pirkanmaa, FinlandManufacturer, Specification developer0000api.fda.gov
Intai Technology Corp. Implants Business UnitTaichung City, TaiwanContract manufacturer0000api.fda.gov
Kico Knee Innovation CompanyFrenchs Forest New South Wales, AustraliaComplaint file establishment, Manufacturer0000api.fda.gov
Medical Action Industries, Inc. 306Arden, NC, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - LaredoLaredo, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer00548api.fda.gov
Medline Industries, LP - SPTWaukegan, IL, United StatesManufacturer, Repackager or relabeler0010api.fda.gov
Medline Industries, LP - Mexicali (MXC)Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Medline Soluciones MedicasNuevo Laredo Tamaulipas, MexicoManufacturer0000api.fda.gov
Nanova Biomaterials IncColumbia, MO, United StatesManufacturer, Specification developer0000api.fda.gov
Ossio Ltd.Caesarea Central, IsraelManufacturer0000api.fda.gov
Osteotec LimitedNewbury West Berkshire, United KingdomExporter to the US, Specification developer0000api.fda.gov
Plastifil SAMendrisio Ticino, SwitzerlandContract manufacturer0000api.fda.gov
Productos Medline S.A. De C.V.NUEVO LAREDO Tamaulipas, MexicoManufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Remex Medical Corp.Taichung, TaiwanComplaint file establishment, Specification developer0000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandManufacturer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer, Exporter to the US0000api.fda.gov
Symmetry Medical, Inc. - ManchesterManchester, NH, United StatesContract manufacturer0000api.fda.gov
Total Joint Orthopedics, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesSpecification developer0000api.fda.gov
X40 TechLa Jolla, CA, United StatesSpecification developer0000api.fda.gov
Xiros LtdYEADON Leeds, United KingdomManufacturer0000api.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.