510(k) K213109 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Auxilock Draw Tight Suture-Based Anchor
| Applicant | Auxein Medical Private Limited, Sonipat, IN |
| Decision | Substantially Equivalent, Aug 22, 2022 |
| Received | Sep 24, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213109
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.