Medical device licence · 102385 · Class 3
HELIX ACP SYSTEM
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed February 13, 2019; ended December 6, 2024. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 102385
- Licence holder
- Nuvasive Inc.San Diego, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 13, 2019
- Ended
- December 6, 2024
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HELIX ACP PLATE
- HELIX ACP SCREW FIXED SELF DRILL
- HELIX ACP SCREW FIXED SELF TAP
- HELIX ACP SCREW VAR SELF DRILL
- HELIX ACP SCREW VAR SELF TAP
- HELIX MINI PLATE
- HELIX MINI SCREW FIX SELF DRILL
- HELIX MINI SCREW FIX SELF TAP
- HELIX MINI SCREW VAR SELF DRILL
- HELIX MINI SCREW VAR SELF TAP
- HELIX R PLATE
- HELIX R SCREW FIXED SELF DRILL
- HELIX R SCREW FIXED SELF TAP
- HELIX R SCREW VAR SELF DRILL
- HELIX R SCREW VAR SELF TAP
- HELIX SCREW BLUNT VARIABLE
- HELIX-T PLATE
- HELIX-T SCREW FIXED SELF DRILL
- HELIX-T SCREW FIXED SELF TAP
- HELIX-T SCREW VAR SELF DRILL
- HELIX-T SCREW VAR SELF TAP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.