K250997 is an FDA 510(k) clearance for the Integrity™ Implant. This device is classified as a Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWX).
Submitted by Anika Therapeutics, Inc. (Beford, US). The FDA issued a Cleared decision on June 17, 2025, 77 days after receiving the submission on April 1, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair..
| 510(k) Number | K250997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2025 |
| Decision Date | June 17, 2025 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OWX - Mesh, Surgical, Non-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 In Tendon Repair. |