510(k) K253027 · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Anchor with Fiber Wire and Disposable Inserter
| Applicant | Ortobio S.A., Maringá, BR |
| Decision | Substantially Equivalent, May 6, 2026 |
| Received | Sep 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253027
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.