510(k) K222501 ยท OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Regeneten Bioinductive Implant
| Applicant | Smith and Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, May 11, 2023 |
| Received | Aug 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222501
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.