510(k) K213110 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor
| Applicant | Auxein Medical Private Limited, Sonipat, IN |
| Decision | Substantially Equivalent, Dec 16, 2022 |
| Received | Sep 24, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213110
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.