Medical device licence · 76611 · Class 3
3DKNEE SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed March 19, 2008; ended November 23, 2018. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 76611
- Licence holder
- Encore Medical, L.P.Austin, TX, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 19, 2008
- Ended
- November 23, 2018
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 3DKNEE SYSTEM - FK/3DKNEE DOWNSIZE NON-POROUD STEMMED TIBIA, RIGHT
- 3DKNEE SYSTEM - FK/3DKNEE DOWNSIZE NON-POROUS STEMMED TIBIA, LEFT
- 3DKNEE SYSTEM - FK/3DKNEE DOWNSIZE POROUS STEMMED TIBIA, LEFT
- 3DKNEE SYSTEM - FK/3DKNEE DOWNSIZE POROUS STEMMED TIBIA, RIGHT
- 3DKNEE SYSTEM - INSERT LEFT CM
- 3DKNEE SYSTEM - INSERT LEFT DCM
- 3DKNEE SYSTEM - INSERT RIGHT CM
- 3DKNEE SYSTEM - INSERT RIGHT DCM
- 3DKNEE SYSTEM - INSERT, LEFT
- 3DKNEE SYSTEM - INSERT, RIGHT
- 3DKNEE SYSTEM - METAL POLY DOMED PATELLA
- 3DKNEE SYSTEM - NON-POROUS FEMUR LEFT
- 3DKNEE SYSTEM - NON-POROUS FEMUR RIGHT
- 3DKNEE SYSTEM - NON-POROUS STEMMED TIBIA LEFT
- 3DKNEE SYSTEM - NON-POROUS STEMMED TIBIA RIGHT
- 3DKNEE SYSTEM - POROUS FEMUR LEFT
- 3DKNEE SYSTEM - POROUS FEMUR RIGHT
- 3DKNEE SYSTEM - POROUS STEMMED TIBIA LEFT
- 3DKNEE SYSTEM - POROUS STEMMED TIBIA RIGHT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.