510(k) K253040 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Aevumed FASE Suture Anchor
| Applicant | Aevumed, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Oct 21, 2025 |
| Received | Sep 22, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253040
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.