510(k) K242631 · OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
REGENETEN Bioinductive Implant
| Applicant | Smith & Nephew Inc., Endoscopy Div., Andover MA, US |
| Decision | Substantially Equivalent, Nov 26, 2024 |
| Received | Sep 3, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242631
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.