510(k) K182121 ยท OLO Orthopedic Stereotaxic Instrument
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Nov 2, 2018 |
| Received | Aug 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182121
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.