Medical device licence · 98501 · Class 3
KYPHON XPEDE BONE CEMENT
Yes: licensed in Canada
Licence status Issued (active); first licensed January 27, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98501
- Licence holder
- Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 27, 2017
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- KYPHON XPEDE BONE CEMENT
- KYPHON XPEDE BONE CEMENT AND KYPHON MIXER PACK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.