Medical device licence · 11845 · Class 3
AGC TOTAL KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 14, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 11845
- Licence holder
- Biomet Orthopedics, Ata Biomet Sports Medicine, Ata Biomet Biologics, Ata Biomet TraumaWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 14, 1999
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AGC ANATOMIC INTERLOK PS FEMORAL
- AGC MODULAR TIBIAL II BEARING INSERT
- AGC MODULAR TIBIAL II TRIAL BEARING
- AGC TOTAL KNEE SYSTEM - AGC TRADITION PRIMARY TIBIAL BEARING
- AGC TOTAL KNEE SYSTEM - TI MODULAR LOCKING SCREW
- AGC TRADITION PRIMARY PROVISIONAL TIBIAL BEARING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.