Medical device licence · 99378 · Class 3
SOVEREIGN SPINAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 5, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99378
- Licence holder
- Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 5, 2017
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SOVEREIGN SPINAL SYSTEM BONE SCREW
- SOVEREIGN SPINAL SYSTEM FIXED ANGLE BONE SCREW
- SOVEREIGN SPINAL SYSTEM INTERBODY SPACER + COVERPLATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.