Data / Medical devices / Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon (OWX): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon (product code OWX, Class 2, 21 CFR 878.3300). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on January 2, 2026, and lists 0 recall events (0 Class I). FDA data exported November 3, 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.
- Product code
- OWX
- Device class
- 2
- Regulation
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Switzerland | 2 |
| United Kingdom | 2 |
| Germany | 1 |
Makers of Mesh, Surgical, Non-Absorbable, 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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Anika Therapeutics, Inc. | Bedford, MA, United States | Manufacturer | 2 | June 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Zurimed Technologies AG | Zurich, Switzerland | Complaint file establishment, Manufacturer | 2 | January 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 1 | May 29, 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 | |
| BBF Sterilisationsservice GMBH | Kernen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Samaplast AG | Sankt Margrethen Sankt Gallen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Specialties Corporation Limited (UK) | Taunton Somerset, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theramicro | Cordova, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiros Ltd | YEADON Leeds, United Kingdom | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 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.