510(k) K253065 · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Aevumed SUPERCYNCH Button System
| Applicant | Aevumed, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Sep 2, 2026 |
| Received | Sep 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253065
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.