510(k) K161210 ยท OUR Sacroiliac Joint Fixation
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
| Applicant | Medtronic Sofamor Danek, Memphis TN, US |
| Decision | Substantially Equivalent, Aug 12, 2016 |
| Received | Apr 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161210
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.