510(k) K212912 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
| Applicant | B-One Ortho, Corp., Cedar Knolls NJ, US |
| Decision | Substantially Equivalent, Nov 4, 2021 |
| Received | Sep 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212912
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.