510(k) K062640 ยท HAW Neurological Stereotaxic Instrument
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
| Applicant | Stryker Instruments, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Dec 14, 2006 |
| Received | Sep 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Software, Part number 6000-650-000.
It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative su Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-650-100. It is part of the product series of the Stryker Navigation System. The system comprises software Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Software, Part number 6000-651-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative su Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Software - Upgrade, Part number 6000-651-100. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-op Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Software - Maintenance, Part number 6000-651-200. It is part of the product series of the Stryker Navigation System. The system comprises software for pr Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Navigation Software - Enable, Part number 6000-651-300. It is part of the product series of the Stryker Navigation System. The system comprises software Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-652-000. It is part of the product series of the Stryker Navigation System. The system comprises software Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Planning Software - Enable, Part number 6000-652-300. It is part of the product series of the Stryker Navigation System. The system comprises software fo Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - SpineMap 3D Module, Part number 6002-650-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle featu Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - SpineMap 3D - Upgrade, Part number 6002-650-100. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle fe Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - OrthoMap 3D - Enable, Part number 6002-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle fea Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - SpineMap 3D - Planning, Part number 6002-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle f Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - OrthoMap 3D Module, Part number 6005-650-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle featu Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - OrthoMap 3D - Enable, Part number 6005-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle fea Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - OrthoMap 3D - Planning, Part number 6005-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle f Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - OrthoMap 3D (Sales Demos), Part number 81-81016. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle fe Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - SpineMap(TM) 3D - Sales Demo SOFTWARE, Part number 81-80045. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - SALES DEMO, Part number 81-81016. provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include com Terminated |
HAW | None listed |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - SALES DEMO, Part number 81-81018. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.