Medical device licence · 69962 · Class 3
S-ROM TOTAL KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 12, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 69962
- Licence holder
- Depuy Ireland UcRingaskiddy, CK, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 12, 2005
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- S-ROM TOTAL KNEE SYSTEM - MODULAR TIBIAL AUGMENT BLOCK
- S-ROM TOTAL KNEE SYSTEM - MODULAR TIBIAL BASE
- S-ROM TOTAL KNEE SYSTEM - MODULAR TIBIAL SLEEVE POROUS COATED
- S-ROM TOTAL KNEE SYSTEM - NOILES MODULAR KNEE FEMORAL SLEEVE
- S-ROM TOTAL KNEE SYSTEM - NOILES ROTATING HINGE FEMORAL COMPONENT
- S-ROM TOTAL KNEE SYSTEM - NOILES ROTATING HINGE KNEE BUMPER
- S-ROM TOTAL KNEE SYSTEM - NOILES ROTATING HINGE KNEE HINGE BEARINGS
- S-ROM TOTAL KNEE SYSTEM - NOILES ROTATING HINGE REPLACEMENT HINGE PIN
- S-ROM TOTAL KNEE SYSTEM - PATELLA DOME
- S-ROM TOTAL KNEE SYSTEM -NOILES ROTATING HINGE DISTAL FEMORAL AUGMENT BLOCK
- S-ROM TOTAL KNEE SYSTEM-NOILES ROTATING HINGE TIBIAL PLATEAU ASS. W BEARING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.