Atlas FDA

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

FDA 510(k) clearance K062640 · decided 2006-12-14

Clearance details

K-number
K062640
Device name
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
Applicant
Stryker Instruments
Decision
Substantially Equivalent
Date received
2006-09-06
Decision date
2006-12-14
Days to decision
99 days
Clearance type
Traditional
Product code
HAW
Device class
2
Regulation number
882.4560
Medical specialty
Neurology
Advisory committee
Neurology
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stryker Navigation System - iNtellect Cranial Software, Part number 6000-650-000. It is pa recall (Z-1402-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 60 recall (Z-1403-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - iNtellect Cranial Software, Part number 6000-651-000. It is pa recall (Z-1404-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - iNtellect Cranial Software - Upgrade, Part number 6000-651-100 recall (Z-1405-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - iNtellect Cranial Software - Maintenance, Part number 6000-651 recall (Z-1406-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - iNtellect Cranial Navigation Software - Enable, Part number 60 recall (Z-1407-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 60 recall (Z-1408-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - iNtellect Cranial Planning Software - Enable, Part number 6000 recall (Z-1409-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - SpineMap 3D Module, Part number 6002-650-000. It provides prec recall (Z-1410-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - SpineMap 3D - Upgrade, Part number 6002-650-100. It provides p recall (Z-1411-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - OrthoMap 3D - Enable, Part number 6002-650-300. It provides pr recall (Z-1412-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - SpineMap 3D - Planning, Part number 6002-651-000. It provides recall (Z-1413-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - OrthoMap 3D Module, Part number 6005-650-000. It provides prec recall (Z-1414-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - OrthoMap 3D - Enable, Part number 6005-650-300. It provides pr recall (Z-1415-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - OrthoMap 3D - Planning, Part number 6005-651-000. It provides recall (Z-1416-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - OrthoMap 3D (Sales Demos), Part number 81-81016. It provides p recall (Z-1417-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - SpineMap(TM) 3D - Sales Demo SOFTWARE, Part number 81-80045. I recall (Z-1418-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - SALES DEMO, Part number 81-81016. provides precise stereostati recall (Z-1419-2011)Stryker Instruments Division of Stryker Corporation2011-02-25
Stryker Navigation System - SALES DEMO, Part number 81-81018. It provides precise stereost recall (Z-1420-2011)Stryker Instruments Division of Stryker Corporation2011-02-25