510(k) K230874 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
| Applicant | Suzhou Endophix Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, May 23, 2023 |
| Received | Mar 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230874
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.