OWW
- Product code
- OWW
- Device name
- Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 10
FDA classification definition
For reinforcement of soft tissue where weakness exists during tendon repair procedures.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251655 | 2025-07-18 | Alafair Biosciences | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Ten | |
| K250021 | 2025-02-27 | Nanofiber Solutions, LLC | Rotium | |
| K242187 | 2024-11-27 | Conmed Corporation | BioBrace® | |
| K241906 | 2024-07-29 | Conmed Corporation | BioBrace® Reinforced Implant | |
| K240817 | 2024-06-14 | Alafair Biosciences, Inc. | VersaWrap |
Official FDA classification page: OWW
Classification and pathway per current FDA publications. Data from openFDA (CC0).