K222501 is an FDA 510(k) clearance for the Regeneten Bioinductive Implant. This device is classified as a Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWY).
Submitted by Smith and Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on May 11, 2023, 266 days after receiving the submission on August 18, 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 | K222501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2022 |
| Decision Date | May 11, 2023 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OWY - Mesh, Surgical, Collagen, 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. |