510(k) K191039 ยท OLO Orthopedic Stereotaxic Instrument
Navigated T2 STRATOSPHERE Inserters and Navigated Templates
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Aug 26, 2019 |
| Received | Apr 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191039
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.