ClearanceBrief
510(k) K062640 ยท HAW Neurological Stereotaxic Instrument

STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000

ApplicantStryker Instruments, Kalamazoo MI, US
DecisionSubstantially Equivalent, Dec 14, 2006
ReceivedSep 6, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K062640

DateFirm and productCodeLinked 510(k)
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed
Feb 25, 2011Stryker 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
HAWNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.