510(k) K994364 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
SYNTHES BUTTON PLATE
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Mar 15, 2000 |
| Received | Dec 27, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994364
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2016 | Synthes (USA) Products LLC Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.