Medical device licence · 97162 · Class 3
VIRAGE OCT SPINAL FIXATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 27, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97162
- Licence holder
- Highridge Medical, LlcWestminster, CO, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 27, 2016
- Devices covered
- 36
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FIX DRILL GUIDE
- VIRAGE ADJUSTABLE OCCIPITAL ROD, TI
- VIRAGE CABLE CONNECTOR
- VIRAGE CLOSURE TOP, HEAD TO HEAD TRANSVERSE CONNECTOR
- VIRAGE CURVED ROD
- VIRAGE DOME NUT, HEAD TO HEAD TRANSVERSE CONNECTOR
- VIRAGE HOOK TRIAL
- VIRAGE HOOK, LATERAL OFFSET
- VIRAGE LAMINAR HOOK
- VIRAGE LATERAL OFFSET CONNECTOR
- VIRAGE NAV ARRAY ORIENTER
- VIRAGE NAV DRILL BIT
- VIRAGE NAV DRILL GUIDE
- VIRAGE NAV LARGE TAP
- VIRAGE NAV POLY SCREWDRIVER
- VIRAGE NAV SMALL TAP
- VIRAGE NAV TAP SLEEVE
- VIRAGE NAV WALTER TUBE
- VIRAGE OCCIPITAL EYELET
- VIRAGE OCCIPITAL PLATE
- VIRAGE OCCIPITAL SCREW
- VIRAGE OCCIPITAL STRAP
- VIRAGE POLYAXIAL SCREW
- VIRAGE POLYAXIAL SCREW, SS
- VIRAGE PRE-CONTOURED OCCIPITAL ROD COCR
- VIRAGE PRE-CONTOURED OCCIPITAL ROD TI
- VIRAGE ROD CONNECTOR SIDE CLOSED
- VIRAGE ROD CONNECTOR, OPEN
- VIRAGE ROD TEMPLATE
- VIRAGE STANDARD CLOSURE TOP
- VIRAGE STRAIGHT ROD COCR
- VIRAGE STRAIGHT ROD, TI
- VIRAGE TRANSITION ROD COCR
- VIRAGE TRANSITION ROD TI
- VIRAGE TRANSVERSE CONNECTOR, HEAD TO HEAD
- VIRAGE TRANSVERSE CONNECTOR, ROD TO ROD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.