510(k) K191066 · NQP Posterior Metal/Polymer Spinal System, Fusion
CD Horizon Astute Spinal System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Oct 3, 2019 |
| Received | Apr 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191066
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.