Medical device licence · 81013 · Class 3
LEGION HINGE KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 2, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81013
- Licence holder
- Smith & Nephew, Inc.Mississauga, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 2, 2009
- Devices covered
- 29
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LEGION HINGE KNEE SYSTEM - BOLT AND SLEEVE KIT
- LEGION HINGE KNEE SYSTEM AXLE FEMUR
- LEGION HINGE KNEE SYSTEM AXLE PLUGS
- LEGION HINGE KNEE SYSTEM DISTAL FEMORAL WEDGE
- LEGION HINGE KNEE SYSTEM DISTAL FEMORAL WEDGE SCREW
- LEGION HINGE KNEE SYSTEM DISTAL FEMORAL WEDGE TRIAL
- LEGION HINGE KNEE SYSTEM FEMORAL TRIAL
- LEGION HINGE KNEE SYSTEM FEMORAL W/AXLE LEFT
- LEGION HINGE KNEE SYSTEM FEMORAL W/AXLE RIGHT
- LEGION HINGE KNEE SYSTEM GUIDED MOTION LOCKING SCREW
- LEGION HINGE KNEE SYSTEM GUIDED MOTION TIB ISRT 6-7 RT
- LEGION HINGE KNEE SYSTEM GUIDED MOTION TIB ISRT SZ 2-3 LT
- LEGION HINGE KNEE SYSTEM GUIDED MOTION TIB ISRT SZ 2-3 RT
- LEGION HINGE KNEE SYSTEM GUIDED MOTION TIB ISRT SZ 4-5 LT
- LEGION HINGE KNEE SYSTEM GUIDED MOTION TIB ISRT SZ 4-5 RT
- LEGION HINGE KNEE SYSTEM GUIDED MOTION TIB ISRT SZ 6-7 LT
- LEGION HINGE KNEE SYSTEM GUIDED MOTION TIBIAL INSERT TRIAL
- LEGION HINGE KNEE SYSTEM HYPEREXTENSION STOP W/AXLE PLUGS
- LEGION HINGE KNEE SYSTEM LINK ASSEMBLY KIT - SZ 2-5
- LEGION HINGE KNEE SYSTEM ROTATING PLATFORM TIBIAL INSERT TRIAL
- LEGION HINGE KNEE SYSTEM TIBIAL BASE LEFT
- LEGION HINGE KNEE SYSTEM TIBIAL BASE RIGHT
- LEGION HINGE KNEE SYSTEM TIBIAL BASE TRIAL
- LEGION HINGE KNEE SYSTEM TRIAL BOX MODULE
- LEGION HINGE KNEE SYSTEM TRIAL LINK
- LEGION HINGE KNEE SYSTEM TRIAL POST
- OXINIUM LEGION HK FEMORAL ASSEMBLY
- OXINIUM LEGION HK THREADED FEMUR AXLE
- OXINIUM LEGION HK TIBIAL BASEPLATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.