510(k) K143350 ยท OWI Bone Fixation Cerclage, Sublaminar
Nile Alternative Fixation
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Feb 25, 2015 |
| Received | Nov 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143350
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.