510(k) K093943 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM
| Applicant | Smith & Nephew Inc., Endoscopy Div., Andover MA, US |
| Decision | Substantially Equivalent, Mar 5, 2010 |
| Received | Dec 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093943
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.