510(k) K193165 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
MectaFix CL Fixation Button with Continuous Loop
| Applicant | Medacta International S.A., Castel San Pietro (Ch), CH |
| Decision | Substantially Equivalent, Feb 10, 2020 |
| Received | Nov 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193165
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.