Medical device licence · 80759 · Class 3
EVOLIS TOTAL KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 29, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80759
- Licence holder
- Medacta International SaCastel San Pietro, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 29, 2009
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CANCELLOUS BONE SCREWS - EVOLIS 6.5MM
- EVOLIS CEMENTED POSTERO-STABLIZED FEMURS
- EVOLIS CEMENTED STANDARD FEMURS
- EVOLIS CEMENTED TIBIAL BASEPLATES
- EVOLIS CEMENTLESS POSTERO-STABLIZED FEMURS (WITH POROUS TITANIUM COATING)
- EVOLIS CEMENTLESS STANDARD FEMURS (WITH POROUS TITANIUM COATING)
- EVOLIS CEMENTLESS TIBIAL BASEPLATES (WITH POROUS TITANIUM COATING)
- EVOLIS INSET PATELLAS
- EVOLIS POSTERO-STABILIZED INSERTS
- EVOLIS RESURFACING PATELLAS
- EVOLIS STANDARD INSERTS
- EVOLIS TIBIAL EXTENSION STEMS
- EVOLIS ULTRA-CONGRUENT FLEX INSERTS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.