510(k) K182119 · NKB Thoracolumbosacral Pedicle Screw System
CD HORIZON Spinal System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Aug 29, 2018 |
| Received | Aug 6, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182119
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.