510(k) K160804 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
INTRAFIX(TM) Advance Tibial Fastener System
| Applicant | Medos International SARL, Le Locle, CH |
| Decision | Substantially Equivalent, Jul 19, 2016 |
| Received | Mar 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160804
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.