Medical device licence · 26455 · Class 3
MODULAR ROTATING HINGE KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 3, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 26455
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 3, 2001
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MODULAR ROTATING HINGE KNEE - TRIAL TIBIAL ROTATING COMPONENT
- MODULAR ROTATING HINGE KNEE REAMER BUSHING
- MODULAR ROTATING HINGE KNEE SYSTEM - BUMPER INSERT/AXLE
- MODULAR ROTATING HINGE KNEE SYSTEM - FEMORAL COMPONENTS
- MODULAR ROTATING HINGE KNEE SYSTEM - TIBAL BASEPLATES
- MODULAR ROTATING HINGE KNEE SYSTEM - TIBIAL INSERTS/COMPONENTS/SLEEVE
- MODULAR ROTATING HINGE KNEE TIBIAL REAMER GUIDE (KEEL)
- MODULAR ROTATING HINGE KNEE TRIAL AXLE
- MODULAR ROTATING HINGE KNEE TRIAL FEMORAL COMPONENT
- MODULAR ROTATING HINGE KNEE TRIAL FEMORAL DISTAL BLOCK
- MODULAR ROTATING HINGE KNEE TRIAL TIBIAL BASEPLATE, KEEL DESIGN
- MODULAR ROTATING HINGE KNEE TRIAL TIBIAL INSERT
- MONOGRAM KNEE FEMORAL REFERENCE COLLAR
- MONOGRAM KNEE IM ROD FEMORAL VALGUS ADAPTOR
- MONOGRAM KNEE TIBIAL REFERENCE COLLAR
- MRH TRIAL + OVER TIB SHRT
- MRH TRIAL CROSSOVER BUMPER
- TIBIAL ROTATING COMPONENT
- TRIAL CROSSOVER AXLE - MODULAR ROTATING HINGE KNEE
- TRIAL TRC
- TRIAL X-OVER TIB BEAR COMP MRH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.