510(k) K123425 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Feb 20, 2013 |
| Received | Nov 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123425
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.