510(k) K192709 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Fixone All Suture Anchor
| Applicant | Aju Pharm Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Dec 15, 2020 |
| Received | Sep 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192709
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.