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Data / Medical devices / Nail, Fixation, Bone

Nail, Fixation, Bone (JDS): 90 FDA-registered makers in 13 countries

90 establishments in 13 countries are registered with the FDA to make Nail, Fixation, Bone (product code JDS, Class 2, 21 CFR 888.3030). 16 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 53 510(k) clearances under this code, the latest on June 12, 2025, and lists 15 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JDS
Device class
2
Regulation
888.3030
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States51
Switzerland12
Germany10
Malaysia5
India3
China2
Austria1
United Kingdom1
Italy1
Ireland1
Poland1
France1
Taiwan1

Makers of Nail, Fixation, 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 developer12September 3, 2020020api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer10June 12, 2025060api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer10June 12, 2025000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer9September 3, 2020000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer7August 10, 2006000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer6December 5, 2011000api.fda.gov
Smith and Nephew Operations Sdn. BhdPenang Pulau Pinang, MalaysiaManufacturer4August 22, 2024000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer3February 20, 2020010api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaComplaint file establishment, Manufacturer1June 10, 2020000api.fda.gov
I.T.S. GMBHLASSNITZHOEHE Steiermark, AustriaManufacturer1June 9, 2008000api.fda.gov
Kaul Medizintechnik GMBHDierdorf Rhineland-Palatinate, GermanyComplaint file establishment, Foreign private label distributor, Specification developer1June 10, 2020000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer1February 20, 2024000api.fda.gov
Orthopedic Designs North America, Inc.Tampa, FL, United StatesManufacturer1March 21, 2002000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer1July 9, 1998000api.fda.gov
Trimed, Inc.Santa Clarita, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1May 5, 1995000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer1February 19, 1980000api.fda.gov
3D Instrumentation Sdn BhdBukit Mertajam Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Alden Tool Company, Inc.Berlin, CT, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH-MedTorqueKenosha, WI, United StatesContract manufacturer0000api.fda.gov
Automatics Tooling Company LtdSalfords Surrey, United KingdomContract manufacturer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Branch Medical GroupEagleville, PA, United StatesContract manufacturer0000api.fda.gov
Branch Medical GroupLimerick, PA, United StatesContract manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer0000api.fda.gov
C & J Industries, Inc.Meadville, PA, United StatesContract manufacturer0000api.fda.gov
CB EnterprisesCanyon Country, CA, United StatesContract manufacturer0000api.fda.gov
Christian Diener GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
CREATEC GmbH & CO. KGFRIEDRICHSHAFEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.Changzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
Friedrich Daniels GMBHSOLINGEN North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Frueh Verpackungstechnik AGFehraltorf Zurich, SwitzerlandContract manufacturer0000api.fda.gov
Fruh Packaging Inc.Exton, 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
GPC Medical LimitedGhaziabad Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Huron Tool & Cutter GrindingFarmingdale, NY, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
Jatex, Inc.Nappanee, IN, 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 (Balsthal)Balsthal Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Bettlach)Bettlach Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Grenchen)Grenchen 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
Leitner AGBusswil Bern, SwitzerlandContract manufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
LX Precision Shanghai Co LtdShanghai, ChinaContract manufacturer0000api.fda.gov
Medshape, Inc.Atlanta, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Moser-Baer AGSumiswald Bern, SwitzerlandContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesComplaint file establishment, Manufacturer, Manufacturer for export0000api.fda.gov
Orthofix SRLBUSSOLENGO Verona, ItalyManufacturer0000api.fda.gov
OrthoxelCork Cork(City), IrelandComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Procon Medizintechnik GMBHAlzenau Bavaria, GermanyContract manufacturer0000api.fda.gov
Ptumedical GMBHSpaichingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Puracon GMBHRosenheim Bavaria, GermanyContract manufacturer0000api.fda.gov
Quadm Technologies, LLCHamilton, NJ, United StatesContract manufacturer0000api.fda.gov
SCT, Inc.Franklin Lakes, NJ, United StatesContract manufacturer0000api.fda.gov
Signus Medizintechnik GMBHALZENAU Bavaria, GermanyComplaint file establishment, Exporter to the US, Manufacturer, Specification developer0000api.fda.gov
Spitrex Orthopedics Switzerland SALe Locle Neuchatel, SwitzerlandContract manufacturer0000api.fda.gov
Steripack Medical Poland SP. Z O.O.Jelcz-Laskowice Dolnoslaskie, PolandContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer0000api.fda.gov
Syntec Scientific Corp.CHANG HUA Changhua, TaiwanContract manufacturer0000api.fda.gov
T & L Sharpening, Inc.Indiana Beach, IN, United StatesContract manufacturer0000api.fda.gov
Tegra MedicalHernando, MS, United StatesContract manufacturer0000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesContract manufacturer0000api.fda.gov
Victoria Precision Inc.Trevose, PA, United StatesContract manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated June 12, 2025. 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.