Medical device licence · 91655 · Class 2
VERTEBRAL BODY BALLOON
Yes: licensed in Canada
Licence status Issued (active); first licensed July 12, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91655
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 12, 2013
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VERTEBRAL AUGMENTATION ACCESS KIT
- VERTEBRAL BODY BALLOON
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.