Medical device licence · 108631 · Class 3
NILE ALTERNATIVE FIXATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 8, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108631
- Licence holder
- K2M, Inc.Leesburg, VA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 8, 2022
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANTI TORQUE ALIGNMENT TUBE
- BAND
- CLAMP ASSEMBLY
- CLAMP ASSEMBLY STERILE
- ROD CONNECTOR, SET SCREW
- SOCKET DRIVER SHAFT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.