Medical device licence · 106591 · Class 2
NAVIGATION INSTRUMENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed August 25, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106591
- Licence holder
- K2M, Inc.Leesburg, VA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 25, 2021
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AWL
- DRILL GUIDE
- EVEREST MI CANNULATED SCREW INSERTER
- EVEREST MI TAPERED THREAD TAP, CANNULATED
- EVEREST POLYAXIAL SCREW INSERTER
- EVEREST TAPERED TAP
- MESA 2 TAP
- MESA POLYAXIAL SCREW INSERTER
- MESA SCREW INSERTER
- MESA SMALL STATURE SCREW INSERTER
- MESA SMALL STATURE TAP
- NARROW LAMINA HOOK PREPARER
- THORACIC PROBE
- XTOWER POLYAXIAL SCREW INSERTER
- YUKON NAVIGATED CERVICAL SCREW INSERTER
- YUKON NAVIGATED CERVICAL TAP
- YUKON NAVIGATED DRILL BIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.