Medical device licence · 106438 · Class 3
MAZOR X SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 21, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106438
- Licence holder
- Mazor Robotics Ltd.Caesarea, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 21, 2021
- Devices covered
- 44
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 360 DEGREE BRIDGE KIT
- ARM GUIDE
- ARM GUIDE KIT
- ARM GUIDE SCREW KIT
- AUXILIARY DRILL GUIDE AND AUXILIARY CANNULA
- BLUNT
- BRANCH KIT
- BRIDGE ADAPTOR KIT
- BRIDGE LOCK KIT
- HEAD PIN
- HEAD PIN KIT
- LATERAL OPTIONAL KIT
- LONG CANNULA
- LONG DRILL
- LONG DRILL GUIDE
- LONG DRILL GUIDE AND LONG CANNULA
- MAZOR X BONE MOUNT SET
- MAZOR X GUIDEWIRE INSTRUMENTS SET
- MAZOR X NAVIGATION CAMERA
- MAZOR X SCAN & PLAN DISPOSABLE KIT
- MAZOR X SPINE DISPOSABLE KIT
- MAZOR X SURGICAL INSTRUMENTS
- MAZOR X SYSTEM
- MIST BRIDGE KIT
- RADIOLUCENT MIS CLAMP KIT
- SA REDUCTION TUBE
- SCHANZ BRIDGE KIT
- SCHANZ CONNECTOR KIT
- SCHANZ SCREW
- SCHANZ SCREW
- SHORT BRANCH KIT
- SHORT CANNULA
- SHORT CLAMP KIT
- SHORT DRILL
- SHORT DRILL GUIDE
- SHORT DRILL GUIDE AND SHORT CANNULA
- SNAPSHOT TRACKER KIT
- STANDARD BRIDGE KIT
- STAR DRIVER KIT
- STERILE CLEAR SLEEVE
- STYLUS MARKER
- SURGEON'S SCREEN STERILE SLEEVE
- SURGICAL SYSTEM SLEEVE
- TALL CLAMP KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.