Medical device licence · 61949 · Class 3
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
Yes: licensed in Canada
Licence status Issued (active); first licensed March 7, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 61949
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 7, 2003
- Devices covered
- 51
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GLOBAL MODULAR REPLACEMENT SYSTEM - ADAPTOR I
- GLOBAL MODULAR REPLACEMENT SYSTEM - ADAPTOR II
- GLOBAL MODULAR REPLACEMENT SYSTEM - ANTEVERTED PROXIMAL FEMORAL COMPONENT
- GLOBAL MODULAR REPLACEMENT SYSTEM - AXLE
- GLOBAL MODULAR REPLACEMENT SYSTEM - BUSHING
- GLOBAL MODULAR REPLACEMENT SYSTEM - CONNECTION PIECE
- GLOBAL MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL COMPONENT
- GLOBAL MODULAR REPLACEMENT SYSTEM - EXTENSION PIECE
- GLOBAL MODULAR REPLACEMENT SYSTEM - PRESSFIT STEM
- GLOBAL MODULAR REPLACEMENT SYSTEM - PROXIMAL FEMORAL COMPONENT
- GLOBAL MODULAR REPLACEMENT SYSTEM - PROXIMAL TIBIAL COMPONENT
- GLOBAL MODULAR REPLACEMENT SYSTEM - PROXIMAL TIBIAL INSERT
- GLOBAL MODULAR REPLACEMENT SYSTEM - TIBIAL ROTATING COMPONENT
- GMRS / MRH KNEE TRIAL TIBIAL ROTATING COMPONENT
- GMRS PRESS FIT STEM FLUTE DRILL GUIDE FOR TRIAL REAMER
- GMRS PRESS FIT STEM REAMER DRIVER
- GMRS TIBIAL RESECTION GUIDE
- GMRS TRIAL AXLE
- GMRS TRIAL BOWED PRESS-FIT STEM
- GMRS TRIAL BUMPER
- GMRS TRIAL CONNECTION PIECE
- GMRS TRIAL DISTAL FEMORAL COMPONENT
- GMRS TRIAL INSERT FOR SMALL PROXIMAL TIBIAL COMPONENT
- GMRS TRIAL LONG-BOWED PRESS-FIT STEM
- GMRS TRIAL PROXIMAL FEMORAL COMPONENT
- GMRS TRIAL PROXIMAL TIBIA
- GMRS TRIAL PROXIMAL TIBIA
- GMRS TRIAL REAMER FOR PRESS FIT STEM HALF SIZE
- GMRS TRIAL STEM BODY EXTENSION PIECE
- GMRS TRIAL TIBIAL ROTATING COMPONENT
- KINEMATIC ROTATING HINGE KNEE TIBIAL FIN/BOX PUNCH GUIDE
- KINEMATIC ROTATING HINGE KNEE TIBIAL STEM PUNCH GUIDE
- KRH KNEE INSTRUMENT TIBIAL TEMPLATE
- MODULAR ROTATING HINGE KNEE FEMORAL A/P CHAMFER CUTTING GUIDE
- MODULAR ROTATING HINGE KNEE FEMORAL CUTTING GUIDE SPACER
- MODULAR ROTATING HINGE KNEE IM TIBIAL STEM BOSS REAMER
- MODULAR ROTATING HINGE TIBIAL OFFSET POSITIONING GUIDE
- MODULAR ROTATING HINGE TIBIAL STEM BOSS REAMER BUSHING
- MONOGRAM INSTRUMENT HEADED NAIL
- MONOGRAM KNEE ANTERIOR SHIM PLATE
- MONOGRAM KNEE BOSS REAMING BUSHING
- MONOGRAM KNEE DISTAL FEMORAL CUTTING BLOCK
- MONOGRAM KNEE DURACON REVISION TIBIAL TEMPLATE
- MONOGRAM KNEE DURACON TRIAL STEM EXTENDER
- MONOGRAM KNEE IM REAMER
- MONOGRAM KNEE TRIAL STEM FEMORAL VALGUS ADAPTOR
- SPECIALTY GMRS TRIAL ADAPTER I TRIAL
- SPECIALTY GMRS TRIAL ADAPTER II TRIAL
- STRYKER TIBIAL STEM REAMER
- TOTAL KNEE INTERCONDYLAR STEPPED DRILL
- TRIAL INTERCALARY STEM W/ FEMALE TAPER GMRS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.