Medical device licence · 106334 · Class 2
ATTUNE KNEE SYSTEM - INSTRUMENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 30, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106334
- Licence holder
- Depuy Ireland UcRingaskiddy, CK, Ireland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 30, 2021
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ATTUNE KNEE SYSTEM DISTRACTION HANDLE
- ATTUNE KNEE SYSTEM FEMORAL
- ATTUNE KNEE SYSTEM FEMORAL CR SIZER
- ATTUNE KNEE SYSTEM FEMORAL PAD
- ATTUNE KNEE SYSTEM FEMORAL PS SIZER
- ATTUNE KNEE SYSTEM FEMORAL SIZER STYLUS
- ATTUNE KNEE SYSTEM FEMORAL TENSOR POST
- ATTUNE KNEE SYSTEM PIN ADJUSTMENT BLOCK
- ATTUNE KNEE SYSTEM STYLUS CYLINDER
- ATTUNE KNEE SYSTEM TIBIAL PAD
- ATTUNE KNEE SYSTEM TIBIAL TOWER LEFT
- ATTUNE KNEE SYSTEM TIBIAL TOWER RIGHT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.