Devices

Device Recall Synaptive Medical BrightMatter Navigator System

Model / Serial
00260001 00260002 00260006 00260007 00260005 00260003 00260004 00260012
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
US: FL, WI, IL, LA, WA.
Product Description
Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.
Manufacturer
Synaptive Medical, Inc.
1 Event
- Recall of Device Recall Synaptive Medical BrightMatter Navigator System

Manufacturer

Synaptive Medical, Inc.

Manufacturer Address
Synaptive Medical, Inc., 101 College Street, Suite 200, MaRS Centre, South Tower, Toronto Canada
Manufacturer Parent Company (2017)
Synaptive Medical, Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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