Medical device licence · 62584 · Class 3
MODULAR REPLACEMENT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 27, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 62584
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 27, 2003
- Devices covered
- 28
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HUMERAL INTERCALARY STEM TRIAL
- MODULAR REPLACEMENT SYSTEM - CROSSOVER TIBIAL BEARING COMPONENTS
- MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL LONG STEM
- MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL LONG STEM WITHOUT BODY
- MODULAR REPLACEMENT SYSTEM - FEMORAL STEM SECTION
- MODULAR REPLACEMENT SYSTEM - FEMORAL STEM SECTION FEMALE TAPER
- MODULAR REPLACEMENT SYSTEM - FEMORAL STEM SECTION WITHOUT BODY
- MODULAR REPLACEMENT SYSTEM - FEMORAL STEM SECTION WITHOUT BODY TAPER
- MODULAR REPLACEMENT SYSTEM - HUMERAL BODY
- MODULAR REPLACEMENT SYSTEM - HUMERAL HEAD
- MODULAR REPLACEMENT SYSTEM - HUMERAL STEM
- MODULAR REPLACEMENT SYSTEM - KINEMATIC KNEE ALL POLY TIBIAL PLUG
- MODULAR REPLACEMENT SYSTEM - KINEMATIC ROTATING HINGE KN MET TIB INSERT
- MRS PEDIATRIC TIBIAL STEM DRILL
- MRS TRIAL CURVED STEM W/ BODY
- MRS TRIAL FEMORAL LONG STEM
- MRS TRIAL HUMERAL STEM WITH BODY
- MRS TRIAL PROXIMAL HUMERUS BODY
- MRS - BODY HUMERAL INTERCALARY STEM TRIAL
- MRS BODY HUM STEM SHO TRIAL
- MRS BODY HUM STEM TRIAL
- MRS PROX HUM CAP TRIAL
- MRS TRIAL HUMERAL STEM WITHOUT BODY
- STEM MRS TRIAL, HUMERAL INTERCALARY
- TRIAL HUMERAL MODULE HUMERAL HEAD MODULAR REPLACEMENT SYSTEM
- TRIAL HUMERAL STEM
- TRIAL PROXIMAL HUMEROUS BODY MALE/FEMALE MODULAR REPLACEMENT SYSTEM
- W/O BODY MRS TRIAL FEMORAL MODULE, STEM SECTION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.