K223538 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 August 17, 2023, 267 days after receiving the submission on November 23, 2022.
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 | K223538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2022 |
| Decision Date | August 17, 2023 |
| Days to Decision | 267 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. |