Medical device licence · 82813 · Class 2
BLAZER VERTEBRAL AUGMENTATION SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed May 12, 2010; ended May 13, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 82813
- Licence holder
- Benvenue Medical, Inc.Santa Clara, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 12, 2010
- Ended
- May 13, 2015
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BLAZER VERTEBRAL AUGMENTATION SYSTEM - CANNULATED INTRODUCER
- BLAZER VERTEBRAL AUGMENTATION SYSTEM - SINGLE STEP INTRODUCER
- BLAZER VERTEBRAL AUGMENTATION SYSTEM- BONE ACCESS DRILL
- BLAZER VERTEBRAL AUGMENTATION SYSTEM- CEMENT DELIVERY NEEDLES
- BLAZER-L (LEFT PEDICLE)
- BLAZER-R (RIGHT PEDICLE)
- KIVA BLAZER - LEFT PEDICLE
- KIVA BLAZER - RIGHT PEDICLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.