Data / Medical devices / Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon / United States
FDA-registered makers of Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (product code OWY). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- Product code
- OWY
- Country
- United States
Makers of Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Embody, Inc. | Norfolk, VA, United States | Manufacturer | 4 | September 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 3 | November 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 1 | September 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| DSM Biomedical, Inc. | Exton, PA, United States | Manufacturer | 1 | December 20, 2013 | 0 | 0 | 0 | api.fda.gov |
| Fibralign Corporation | Union City, CA, United States | Manufacturer | 1 | January 8, 2016 | 0 | 0 | 0 | api.fda.gov |
| Tybr Health, Inc. | Houston, TX, United States | Complaint file establishment, Specification developer | 1 | June 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Collagen Matrix, Inc. | Oakland, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen | Eden Prairie, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConMed Corporation | New Haven, CT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeNet Health | Virginia Bch, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeNet Health | Plainfield, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linvatec Corporation | Largo, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.K. Manufacturing | Danbury, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.