510(k) K190165 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Capstone Control Spinal System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, May 6, 2019 |
| Received | Jan 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190165
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.