K251655 is an FDA 510(k) clearance for the VersaCoat Tendon Protector (VTP-44G2). This device is classified as a Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWW).
Submitted by Alafair Biosciences (Austin, US). The FDA issued a Cleared decision on July 18, 2025, 49 days after receiving the submission on May 30, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures..
| 510(k) Number | K251655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2025 |
| Decision Date | July 18, 2025 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OWW - Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures. |