510(k) K163581 ยท OLO Orthopedic Stereotaxic Instrument
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Apr 14, 2017 |
| Received | Dec 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163581
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.