510(k) K243843 ยท OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Tendon Protect (50242)
| Applicant | Kerecis Limited, Isafjordur, IS |
| Decision | Substantially Equivalent, Jun 4, 2025 |
| Received | Dec 13, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243843
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.