Medical device licence · 91650 · Class 2
RAVINE LATERAL ACCESS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 11, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91650
- Licence holder
- K2M, Inc.Leesburg, VA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 11, 2013
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RAVINE LATERAL ACCESS - ANGLED PITUITARY
- RAVINE LATERAL ACCESS - BAYONETED LONG PENFIELD
- RAVINE LATERAL ACCESS - BI-POLAR FORCEPS (STRAIGHT)
- RAVINE LATERAL ACCESS - DISSECTOR
- RAVINE LATERAL ACCESS - FIXATION PIN
- RAVINE LATERAL ACCESS - FIXATION PIN DRIVER
- RAVINE LATERAL ACCESS - GRAFT CONTAINMENT RAMP
- RAVINE LATERAL ACCESS - GUIDE WIRE
- RAVINE LATERAL ACCESS - LATERAL ACCESS BLADE
- RAVINE LATERAL ACCESS - LATERAL ACCESS BLADE SHIM
- RAVINE LATERAL ACCESS - LATERAL ACCESS SHIM EXTRACTOR
- RAVINE LATERAL ACCESS - LATERAL ACCESS SHIM INSERTER
- RAVINE LATERAL ACCESS - NERVE RETRACTOR
- RAVINE LATERAL ACCESS - RONGEUR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.