Skip to the page
Get started – free

Data / Medical devices / Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Appliance, Fixation, Nail/Blade/Plate Combination, Single Component (KTW): 34 FDA-registered makers in 9 countries

34 establishments in 9 countries are registered with the FDA to make Appliance, Fixation, Nail/Blade/Plate Combination, Single Component (product code KTW, Class 2, 21 CFR 888.3030). 12 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 38 510(k) clearances under this code, the latest on June 20, 2019, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
KTW
Device class
2
Regulation
888.3030
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States17
Switzerland7
Germany4
United Kingdom1
Italy1
South Korea1
Taiwan1
India1
France1

Makers of Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

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 developer8March 20, 2008000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer7September 6, 2001000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer4September 6, 2001000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer3June 22, 2017000api.fda.gov
Implants Intl. Ltd.THORNABY-ON-TEES Stockton-on-Tees, United KingdomManufacturer2June 29, 1999000api.fda.gov
Orthofix SRLBUSSOLENGO Verona, ItalyManufacturer2September 20, 2012000api.fda.gov
Stryker Sustainability SolutionsTempe, AZ, United StatesSpecification developer2June 24, 2002000api.fda.gov
Stryker Sustainability Solutions PhoenixPhoenix, AZ, United StatesReprocessor2June 24, 2002000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer1September 2, 1986000api.fda.gov
Jeil Medical CorporationSeoul, South KoreaManufacturer1October 25, 2002000api.fda.gov
Paonan Biotech Co., LtdTaipei, TaiwanManufacturer1June 20, 2019000api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandManufacturer1August 4, 2000000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaComplaint file establishment, Manufacturer0000api.fda.gov
CREATEC GmbH & CO. KGFRIEDRICHSHAFEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Eptam West LLCColorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
General Machine, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
HG Medical GmbHRaisting Bavaria, GermanyContract 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 (Bettlach)Bettlach Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Grenchen)Grenchen 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
Kaul Medizintechnik GMBHDierdorf Rhineland-Palatinate, GermanyComplaint file establishment, Foreign private label distributor, Specification developer0000api.fda.gov
Kammerer Medical Systems GmbH & Co. KGStockach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medtech LLCMillington, TN, United StatesContract manufacturer0000api.fda.gov
Mount MFGMarquette, MI, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Paragon 28Englewood, CO, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer0000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov

Updated June 20, 2019. 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.