Medical device licence · 99449 · Class 3
EVOLUTION REVISION KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 26, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99449
- Licence holder
- Microport Orthopedics Inc.Arlington, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 26, 2017
- Devices covered
- 25
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EVOLUTION CANAL FILLING STEM EXTENSION
- EVOLUTION CEMENTED STEM EXTENSION
- EVOLUTION REAMER STREAMLINED FEMUR
- EVOLUTION REVISION CANAL FILLING STEM EXTENSION TRIAL
- EVOLUTION REVISION CEMENTED STEM EXTENSION TRIAL
- EVOLUTION REVISION MONOLITHIC TIBIA BASEPLATE TRIAL
- EVOLUTION REVISION OFFSET REAMER
- EVOLUTION REVISION PASS THRU SCREW
- EVOLUTION REVISION PRESSFIT KEEL- MODULAR
- EVOLUTION REVISION REAMER
- EVOLUTION REVISION SIDE LOCK SCREW
- EVOLUTION REVISION SP KEEL PUNCH
- EVOLUTION REVISION SP REAMER
- EVOLUTION REVISION STEM ADAPTER W/SCREWS
- EVOLUTION REVISION STEM CAP
- EVOLUTION REVISION STEM EXTENSION SCREW
- EVOLUTION REVISION TIB HALF AUG
- EVOLUTION REVISION TIBIA BASEPLATE PROFILE TRIAL
- EVOLUTION REVISION TIBIAL BASE W/PLUGS
- EVOLUTION REVISION TRIAL BASE IMPACTOR
- EVOLUTION REVISION TRUNNION REAMER
- EVOLUTION STEMMED CS SULCUS BURR
- EVOLUTION STEMMED FEMORAL CS
- EVOLUTION TIB OFFSET ADAPTER W/SCREWS
- EVOLUTION TIBIAL BLOCK AUGMENT W/SCREW & HANDLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.