Medical device licence · 108224 · Class 3
ATTUNE KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 2, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108224
- Licence holder
- Depuy Ireland UcRingaskiddy, CK, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 2, 2022
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ATTUNE KNEE SYSTEM ALL POLY TIBIAL IMPLANT CRUCIATE RETAINING
- ATTUNE KNEE SYSTEM ALL POLY TIBIAL IMPLANT POSTERIOR STABILIZED
- ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING MEDIAL STABILIZED LEFT
- ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING MEDIAL STABILIZED RIGHT
- ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL FIXED BEARING MEDIAL STABILIZED LEFT
- ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL FIXED BEARING MEDIAL STABILIZED RIGHT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.