510(k) K172328 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
SOVEREIGN Spinal System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Nov 2, 2017 |
| Received | Aug 2, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172328
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.