Medical device licence · 7465 · Class 2
BLACK MAX HIGH PERFORMANCE INSTRUMENT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 12, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 7465
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 12, 1999
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BLACK MAX HIGH PERFORM. INST. SYS - LOW PRESS. SWIVEL/ANGLE MOTOR ASSEMBLY
- BLACK MAX HIGH PERFORMANCE INSTRUMENT SYSTEM - CONTROLLED DEPTH ATTACHMENT
- BLACK MAX HIGH PERFORMANCE INSTRUMENT SYSTEM - CRANIOTOME
- BLACK MAX HIGH PERFORMANCE INSTRUMENT SYSTEM - DRILL GUIDE
- BLACK MAX HIGH PERFORMANCE INSTRUMENT SYSTEM - MICRO REVISION ATTACHMENTS
- BLACK MAX HIGH PERFORMANCE INSTRUMENT SYSTEM - MINIMALLY INVASIVE ATTACH.
- BLACK MAX HIGH PERFORMANCE INSTRUMENT SYSTEM - MOTORS
- BLACK MAX HIGH PERFORMANCE INSTRUMENT SYSTEM - SPEED REDUCER
- BLACK MAX HIGH PERFORMANCE INSTRUMENT SYSTEM - STRAIGHT ATTACHMENTS
- SAGITTAL SAW FOR USE WITH BLACK MAX SYSTEMS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.