510(k) K254055 · MAI Fastener, Fixation, Biodegradable, Soft Tissue
OSSIOfiber® Suture Anchor
| Applicant | OSSIO , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Feb 24, 2026 |
| Received | Dec 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254055
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.