Medical device licence · 75307 · Class 3
SIGMA HP PARTIAL KNEE
Yes: licensed in Canada
Licence status Issued (active); first licensed October 26, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 75307
- Licence holder
- Depuy Ireland UcRingaskiddy, CK, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 26, 2007
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SIGMA HP - ALL POLY TIBIAL COMPONENT
- SIGMA HP - UNICOMPARTMENTAL FEMORAL, CEMENTED
- SIGMA HP PARTIAL KNEE AP TIBIAL KEEL TRIAL
- SIGMA HP PARTIAL KNEE TIBIAL PEG DRILL
- SIGMA HP PARTIAL KNEE UNI FEMORAL PEG DRILL
- SIGMA HP PARTIAL KNEE UNI FEMORAL TRIAL
- SIGMA HP PARTIAL KNEE UNI KEEL TRIAL
- SIGMA HP- UNICOMPARTMENTAL FIXED BEARING INSERT
- SIGMA HP- UNICOMPARTMENTAL FIXED BEARING TIBIAL TRAY, CEMENTED
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.