Medical device licence · 100653 · Class 3
PERSONA PARTIAL KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 28, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100653
- 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
- February 28, 2018
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PERSONA PARTIAL KNEE SYSTEM - ARTICULAR SURFACE INSERTER TIP
- PERSONA PARTIAL KNEE SYSTEM - ARTICULAR SURFACE PROVISIONAL MEDIAL
- PERSONA PARTIAL KNEE SYSTEM - FEMORAL PEG DRILL
- PERSONA PARTIAL KNEE SYSTEM - FEMORAL PROVISIONAL
- PERSONA PARTIAL KNEE SYSTEM - PARTIAL FEMUR CEMENTED
- PERSONA PARTIAL KNEE SYSTEM - PARTIAL TIBIAL CEMENTED
- PERSONA PARTIAL KNEE SYSTEM - TIBIAL PROVISIONAL
- PERSONA PARTIAL KNEE SYSTEM - VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE PARTIAL ARTICULAR SURFACE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.