510(k) K162198 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
GFS Ultimate
| Applicant | Parcus Medical, LLC, Sarasota FL, US |
| Decision | Substantially Equivalent, Nov 18, 2016 |
| Received | Aug 5, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162198
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.