510(k) K004027 ยท HAW Neurological Stereotaxic Instrument
STRYKER REMOTE SURGICAL PLANNING SYSTEM
| Applicant | Stryker Instruments, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Jan 24, 2001 |
| Received | Dec 27, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K004027
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.