510(k) K992927 ยท HAW Neurological Stereotaxic Instrument
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
| Applicant | Surgical Navigation Technologies, Inc., Broomfield CO, US |
| Decision | Substantially Equivalent, Dec 29, 1999 |
| Received | Aug 31, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992927
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2016 | Medtronic Navigation, Inc. S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.
Product Usage:
The StealthStation System is intended as an aid f Terminated |
HAW | None listed |
| Aug 13, 2013 | Medtronic Navigation, Inc. StealthStation S7 Framelink Software version 5.4.
Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures. Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.