510(k) K193011 · NKB Thoracolumbosacral Pedicle Screw System
CD Horizon Fenestrated Screw Set
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jan 10, 2020 |
| Received | Oct 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193011
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.