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Data / Medical devices / Component, Traction, Invasive

Component, Traction, Invasive (JEC): 43 FDA-registered makers in 7 countries

43 establishments in 7 countries are registered with the FDA to make Component, Traction, Invasive (product code JEC, Class 2, 21 CFR 888.3040). 19 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 85 510(k) clearances under this code, the latest on April 23, 2021, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JEC
Device class
2
Regulation
888.3040
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States25
Switzerland8
Germany3
Malaysia3
France2
Canada1
Italy1

Makers of Component, Traction, Invasive

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
STRYKER GmbHSELZACH Solothurn, SwitzerlandManufacturer12January 14, 2011010api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer7June 16, 1994000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer4August 24, 2007000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer3February 19, 1997010api.fda.gov
Hand Biomechanics Lab, Inc.Sacramento, CA, United StatesManufacturer3October 22, 2018010api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesSpecification developer2January 11, 1990000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer2December 15, 1999000api.fda.gov
G-5 Florida LLCJax, FL, United StatesManufacturer2March 2, 2020010api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer2December 15, 1999000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesRepackager or relabeler, Specification developer2April 4, 1995000api.fda.gov
Virak Orthopedics LLCMadison, NJ, United StatesRepackager or relabeler, Specification developer2October 10, 2019000api.fda.gov
Arbutus Medical, IncBurnaby British Columbia, CanadaManufacturer1April 23, 2021000api.fda.gov
Biomet FranceValence Drome, FranceManufacturer1November 21, 1991000api.fda.gov
JMG Machine, Inc.La Mirada, CA, United StatesContract manufacturer, Manufacturer1February 22, 1994000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer1August 25, 2004000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor1December 28, 2016000api.fda.gov
Orthofix SRLBUSSOLENGO Verona, ItalyManufacturer1April 4, 1995000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer1August 24, 2007000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer1August 24, 2007000api.fda.gov
Advanced Concept Innovations LLCLakeland, FL, United StatesContract manufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Composites Busch SAPorrentruy Jura, SwitzerlandContract manufacturer0000api.fda.gov
CREATEC GmbH & CO. KGFRIEDRICHSHAFEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
HN And M GMBHDerendingen Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
HPC MedxHanover, PA, United StatesContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Bettlach)Bettlach Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
NUTEK Orthopaedics, IncFort Lauderdale, FL, United StatesSpecification developer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Spitrex Orthopedics Switzerland SALe Locle Neuchatel, SwitzerlandContract 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
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer0000api.fda.gov
Stryker Sustainability SolutionsTempe, AZ, United StatesSpecification developer0000api.fda.gov
Stryker Sustainability Solutions PhoenixPhoenix, AZ, United StatesReprocessor0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov

Updated April 23, 2021. 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.