510(k) K140454 ยท OLO Orthopedic Stereotaxic Instrument
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, May 22, 2014 |
| Received | Feb 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140454
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2023 | Medtronic Sofamor Danek USA, Inc CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.