Data / Medical devices / Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (OWW): 11 FDA-registered makers in 2 countries
11 establishments in 2 countries are registered with the FDA to make Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (product code OWW, Class 2, 21 CFR 878.3300). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on July 18, 2025, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- OWW
- Device class
- 2
- Regulation
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Switzerland | 1 |
Makers of Mesh, Surgical, 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 |
|---|---|---|---|---|---|---|---|---|
| Alafair Biosciences, Inc. | Austin, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | July 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| ConMed Corporation | New Haven, CT, United States | Specification developer | 3 | November 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | November 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Artelon | Atl, GA, United States | Manufacturer | 1 | May 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| Celestray Biotech Company, LLC. | Bethesda, MD, United States | Specification developer | 1 | July 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| International Life Sciences | Sandy Springs, GA, United States | Specification developer | 1 | May 26, 2023 | 0 | 1 | 0 | api.fda.gov |
| Nanofiber Solutions LLC | Dublin, OH, United States | Manufacturer | 1 | February 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Allosource | Centennial, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boylston Surgical LLC | Osterville, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geistlich Pharma AG | WOLHUSEN Luzern, Switzerland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, Inc. | Grand Rapids, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 18, 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.