K160364 is an FDA 510(k) clearance for the VersaWrap Tendon Protector. This device is classified as a Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWW).
Submitted by Alafair Biosciences, Inc. (Austin, US). The FDA issued a Cleared decision on June 10, 2016, 122 days after receiving the submission on February 9, 2016.
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 | K160364 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2016 |
| Decision Date | June 10, 2016 |
| Days to Decision | 122 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. |