Medical device licence · 106467 · Class 2
K2M GENERAL INSTRUMENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 28, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106467
- Licence holder
- K2M, Inc.Leesburg, VA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 28, 2021
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANGLED DISC WEDGE
- DISC WEDGE
- FR SUCTION LONG
- INTEGRATED GRAFT RAMPS
- LORDOTIC MODULAR TRIAL
- PARALLEL TRIAL
- TEMPORARY FIXATION PIN
- TRIAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.