510(k) K192484 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Fixone Biocomposite Anchor
| Applicant | Aju Pharm Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Mar 11, 2020 |
| Received | Sep 10, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192484
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.