Devices

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
1 Event
- Recall of Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Planning Software Enable

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

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