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Data / Medical devices / Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (OWY): 18 FDA-registered makers in 3 countries

18 establishments in 3 countries are registered with the FDA to make Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (product code OWY, Class 2, 21 CFR 878.3300). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on September 30, 2025, and lists 0 recall events (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
OWY
Device class
2
Regulation
878.3300
Medical specialty
General, Plastic Surgery
Implant
Yes

Makers by country

CountryMakers
United States15
Iceland2
Costa Rica1

Makers of Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

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
Embody, Inc.Norfolk, VA, United StatesManufacturer4September 19, 2025000api.fda.gov
Arthrocare CorporationCoyol Alajuela, Costa RicaManufacturer3November 26, 2024000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer3November 26, 2024000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer1September 30, 2025000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesManufacturer1December 20, 2013000api.fda.gov
Fibralign CorporationUnion City, CA, United StatesManufacturer1January 8, 2016000api.fda.gov
Kerecis EhfIsafjordur Vestfiroir, IcelandComplaint file establishment, Manufacturer1June 4, 2025000api.fda.gov
Kerecis EhfIsafjordur Vestfiroir, IcelandComplaint file establishment, Manufacturer1June 4, 2025000api.fda.gov
Tybr Health, Inc.Houston, TX, United StatesComplaint file establishment, Specification developer1June 6, 2025000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Collagen Matrix, Inc.Oakland, NJ, United StatesContract manufacturer0000api.fda.gov
COLLAGEN SOLUTIONS/TISSX LLC d/b/a EvergenEden Prairie, MN, United StatesContract manufacturer0000api.fda.gov
ConMed CorporationNew Haven, CT, United StatesSpecification developer0000api.fda.gov
LifeNet HealthVirginia Bch, VA, United StatesContract manufacturer0000api.fda.gov
LifeNet HealthPlainfield, IN, United StatesContract manufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov

Updated September 30, 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.