Devices

Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Planning Software

  • Model / Serial
    Verisions 1.0 and 1.1; all batches: J3500F3002; J4900F3002; JAQ00F3002; K2A00F3002; K7W00F3003; K8T00F3003; KB500F3003; KBT00F3003; L1E00F3003; L1S00F3003; L4700F3003; L6U00F3001; and L7V00F3003
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • Product Description
    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 for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation
  • 1 Event

Manufacturer

Stryker Instruments Division of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Planning Software
  • Model / Serial
    Verisions 1.0 and 1.1; all batches: H2200F3002; H3D00F3003; H7900F3003; H7P00F3003; H9U00F3003; and HC400F3003.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • Product Description
    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 for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation
Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Planning Software Enable
  • Model / Serial
    Verisions 1.0 and 1.1; all batch J3H00F3002
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • Product Description
    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 for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation