510(k) K993239 ยท HAW Neurological Stereotaxic Instrument
STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
| Applicant | Stryker Corp., Kalamazoo MI, US |
| Decision | Substantially Equivalent, Jan 18, 2000 |
| Received | Sep 27, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993239
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments Navigation System II- CART, Stryker Navigation, Kalamazoo, MI; Stryker REF 7700-100-000.
Intended to be used as a component of the Navigation System II. Terminated |
HAW | None listed |
| Nov 20, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments Navigation System II PC SPC-1 Assembly, Stryker Navigation, Kalamazoo, MI; REF 7700-101-201.
The Stryker Navigation System II is a computer-aided surgery platform, supporting surg Terminated |
HAW | None listed |
| Oct 3, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000. Terminated |
HAW | None listed |
| Oct 3, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000. Terminated |
HAW | None listed |
| Oct 3, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064. Terminated |
HAW | None listed |
| Oct 3, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800, Stryker # 6000-200-000. Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.