Medical device licence · 36029 · Class 3
SUMMIT HIP STEMS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 31, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 36029
- Licence holder
- Depuy Ireland UcRingaskiddy, CK, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- January 31, 2002
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SUMMIT BASIC CEMENTED
- SUMMIT BASIC PRESS-FIT
- SUMMIT CEMENTED STEM WITH HIGH OFFSET
- SUMMIT CEMENTED STEM WITH STANDARD OFFSET
- SUMMIT DUOFIX FEMORAL STEM WITH HIGH OFFSET
- SUMMIT DUOFIX FEMORAL STEM WITH STANDARD OFFSET
- SUMMIT POROUS STEM WITH HIGH OFFSET
- SUMMIT POROUS STEM WITH STANDARD OFFSET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.