OWW
10 FDA 510(k) clearances · Product code
122 daysmedian time to decision
346 days90th percentile
10clearances measured
FDA profile
- Official device name
- Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- For reinforcement of soft tissue where weakness exists during tendon repair procedures.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (K251655) | Alafair Biosciences | 2025-07-18 |
| Rotium (K250021) | Nanofiber Solutions, LLC | 2025-02-27 |
| BioBrace® (K242187) | Conmed Corporation | 2024-11-27 |
| BioBrace® Reinforced Implant (K241906) | Conmed Corporation | 2024-07-29 |
| VersaWrap (K240817) | Alafair Biosciences, Inc. | 2024-06-14 |
| SpinMedix Absorbable Fibrous Membrane (K222220) | Celestray Biotech Company, LLC., | 2023-07-06 |
| FlexBand; FlexPatch; FlexBand Plus (K230316) | International Life Sciences | 2023-05-26 |
| The BioBrace Implant (K203267) | Biorez, Inc. | 2021-04-30 |
| VersaWrap Tendon Protector (K160364) | Alafair Biosciences, Inc. | 2016-06-10 |
| STR GRAFT (K121216) | Soft Tissue Regeneration, Inc. | 2012-11-21 |
Track OWW automatically
Every clearance here is in the API, with alerts when new ones post.