Medical device licence · 94191 · Class 3
ALEUTIAN INTERBODY SYSTEMS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 7, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 94191
- Licence holder
- K2M, Inc.Leesburg, VA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 7, 2014
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BONE FUNNEL
- LORDOTIC ANGLED TRIAL
- LORDOTIC TRIAL
- PARALLEL TRIAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.