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Data / Medical devices / Prosthesis, Toe, Hemi-, Phalangeal / United States

FDA-registered makers of Prosthesis, Toe, Hemi-, Phalangeal in the United States: 30 establishments

30 establishments in the United States are registered with the FDA to make Prosthesis, Toe, Hemi-, Phalangeal (product code KWD). 16 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Prosthesis, Toe, Hemi-, Phalangeal
Product code
KWD
Country
United States

Makers of Prosthesis, Toe, Hemi-, Phalangeal in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer7October 22, 2013000api.fda.gov
Arthrosurface, Inc.W Bridgewater, MA, United StatesManufacturer5August 14, 2019000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer5October 22, 2013010api.fda.gov
Vilex LLCMcminnville, TN, United StatesManufacturer3July 20, 2011000api.fda.gov
Accufix Surgical, Inc.Laramie, WY, United StatesSpecification developer2February 29, 2024000api.fda.gov
Biopoly, LLCFort Wayne, IN, United StatesManufacturer2November 22, 2022000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesManufacturer2October 30, 2012010api.fda.gov
OsteomedAddison, TX, United StatesManufacturer, Specification developer2August 1, 2008000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer2January 14, 2010000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer1January 3, 2007000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer1January 3, 2007000api.fda.gov
Hyalex OrthopaedicsLexington, MA, United StatesManufacturer1April 3, 2026000api.fda.gov
Life SpineHuntley, IL, United StatesSpecification developer1February 1, 2017000api.fda.gov
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer, Repackager or relabeler1February 6, 2012000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesComplaint file establishment, Specification developer1November 28, 2007000api.fda.gov
restor3d, inc.Durham, NC, United StatesManufacturer1May 25, 2022010api.fda.gov
Cep Bio-Coat, LLCFarmington Hills, MI, United StatesContract manufacturer0000api.fda.gov
Disruptive Medtech, LLCLaramie, WY, United StatesContract manufacturer0000api.fda.gov
Medical Device And Implants LLCLancaster, PA, United StatesContract manufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Microcision LLCPennsauken, NJ, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Precision Metal ProductsMilford, CT, United StatesContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Restoration Medical PolymersColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Sites Medical, LLCColumbia City, IN, United StatesContract 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.