510(k) K202883 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Sterile bone screw (PEEK ACL screw)
| Applicant | Osteonic Co., Ltd., Guro-Gu, KR |
| Decision | Substantially Equivalent, Nov 25, 2020 |
| Received | Sep 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202883
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.