Medical device licence · 108762 · Class 3
ANTERALIGN TL SPINAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 12, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 108762
- 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 12, 2023
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANTERALIGN SPINAL SYSTEM WITH TITAN NANOLOCK MINIPLATE
- ANTERALIGN SPINAL SYSTEM WITH TITAN NANOLOCK SURFACE TECHNOLOGY NAVIGATED INTERBODY INSERTER
- ANTERALIGN SPINAL SYSTEM WITH TITAN NANOLOCK SURFACE TECHNOLOGY SCREW
- ANTERALIGN SPINAL SYSTEM WITH TITAN NANOLOCK TL SPACER
- ANTERALIGN SPINAL SYSTEM WITH TITAN NANOLOCK TL TRIAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.