510(k) K231322 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Fix2Lock(PEEK Self Punching)
| Applicant | Osteonic Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Jun 7, 2023 |
| Received | May 8, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231322
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.