510(k) K190892 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
MectaScrew PEEK Interference Screw
| Applicant | Medacta International S.A., Castel San Pietro (Ch), CH |
| Decision | Substantially Equivalent, Jun 4, 2019 |
| Received | Apr 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190892
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.