510(k) K254306 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Aevumed FENIX Suture Anchor
| Applicant | Aevumed, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Mar 4, 2026 |
| Received | Dec 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254306
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.