510(k) K133444 ยท HAW Neurological Stereotaxic Instrument
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Jul 25, 2014 |
| Received | Nov 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133444
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2020 | Medtronic Navigation, Inc. StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous proced Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.