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Data / Medical devices / Fastener, Fixation, Biodegradable, Soft Tissue / United States

FDA-registered makers of Fastener, Fixation, Biodegradable, Soft Tissue in the United States: 46 establishments

46 establishments in the United States are registered with the FDA to make Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI). 24 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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Device
Fastener, Fixation, Biodegradable, Soft Tissue
Product code
MAI
Country
United States

Makers of Fastener, Fixation, Biodegradable, Soft Tissue in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Arthrex, Inc.Naples, FL, United StatesManufacturer, Specification developer39August 7, 2026020api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer36February 5, 2025060api.fda.gov
Linvatec CorporationLargo, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer17October 15, 2025010api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer, Specification developer11March 18, 2020020api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer9March 18, 2020030api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer6January 15, 2020000api.fda.gov
Nanofiber Solutions LLCDublin, OH, United StatesManufacturer4July 29, 2024000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer4May 23, 2025000api.fda.gov
Acuitive TechnologiesAllendale, NJ, United StatesManufacturer3February 24, 2021000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Contract manufacturer, Manufacturer3October 15, 2025010api.fda.gov
Parcus Medical, L.L.C.Sarasota, FL, United StatesManufacturer3September 18, 2023000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer2August 25, 2000000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer2April 11, 2006000api.fda.gov
Nanova Biomaterials IncColumbia, MO, United StatesManufacturer2May 5, 2017000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer2April 11, 2013000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer2February 9, 2001000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler2November 19, 2004000api.fda.gov
Embody, Inc.Norfolk, VA, United StatesManufacturer1April 8, 2022000api.fda.gov
Orthopedic Sciences, IncOverland Park, KS, United StatesSpecification developer1November 3, 2016000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1July 21, 1994000api.fda.gov
SportCareHidalgo, TX, United StatesSpecification developer1December 25, 2021000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer1May 13, 2013000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer1May 13, 2013000api.fda.gov
Ziptek LLCSarasota, FL, United StatesSpecification developer1March 13, 2017000api.fda.gov
Atc Technologies Inc.Wilmington, MA, United StatesContract manufacturer0000api.fda.gov
Aptyx - CharlotteCharlotte, NC, United StatesContract manufacturer0000api.fda.gov
Arthrex California Technology, IncorporatedSanta Barbara, CA, United StatesManufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
C&A Tool Engineering, Inc. Auburn PlantAuburn, IN, United StatesContract manufacturer0000api.fda.gov
C+a Tool Engineering, Inc.Churubusco, IN, United StatesContract manufacturer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
Conextions IncSalt Lake City, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
Lifenet HealthVirginia Beach, VA, United StatesContract manufacturer0000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer0000api.fda.gov
Life Science OutsourcingSomersworth, NH, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
LifeNet HealthVirginia Bch, VA, United StatesContract manufacturer0000api.fda.gov
LifeNet HealthPlainfield, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer0000api.fda.gov
Spectrum Plastics GroupSaint Louis Park, MN, United StatesContract manufacturer0000api.fda.gov
Tesco Associates, Inc.Tyngsboro, MA, 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.