510(k) K161332 ยท OWI Bone Fixation Cerclage, Sublaminar
NILE Proximal Fixation Spinal System
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Apr 5, 2017 |
| Received | May 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161332
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.