510(k) K043088 ยท HAW Neurological Stereotaxic Instrument
MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
| Applicant | Medtronic Surgical Navigation Technologies, Louisville CO, US |
| Decision | Substantially Equivalent, Jan 5, 2005 |
| Received | Nov 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043088
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2006 | Medtronic Navigation, Inc AxiEM EM Knee Kit, and associated workstation. Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.