510(k) K163181 · OWI Bone Fixation Cerclage, Sublaminar
TRANSLACE Spinal Tethering System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, May 16, 2017 |
| Received | Nov 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163181
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.