510(k) K163301 · NKB Thoracolumbosacral Pedicle Screw System
CD HORIZON® Spinal System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Dec 20, 2016 |
| Received | Nov 22, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163301
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.