Medical device licence · 85804 · Class 3
RESTORIS MCK (KNEE REPLACEMENT SYSTEM)
Yes: licensed in Canada
Licence status Issued (active); first licensed April 14, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85804
- Licence holder
- Mako Surgical Corp.Weston, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 14, 2011
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MAKO X3 UNI ONLAY TIBIAL INSERT
- RESTORIS MCK BASEPLATE TEMPLATE
- RESTORIS MCK BASEPLATE TRIAL
- RESTORIS MCK FEMORAL
- RESTORIS MCK FEMORAL TEMPLATE
- RESTORIS MCK FEMORAL TRIAL
- RESTORIS MCK ONLAY INSERT TRIAL
- RESTORIS MCK PATELLA CUT GUIDE
- RESTORIS MCK PATELLA DOME TRIAL
- RESTORIS MCK PATELLA PROTECTOR
- RESTORIS MCK PATELLA RESECTION CLAMP
- RESTORIS MCK PATELLA RESURFACING ROUND DOME
- RESTORIS MCK PATELLA SIZING GUIDE
- RESTORIS MCK PATELLOFEMORAL
- RESTORIS MCK PATELLOFEMORAL TRIAL
- RESTORIS MCK PEG DRILL
- RESTORIS MCK PF TEMPLATE
- RESTORIS MCK TIBIAL BASEPLATE
- RESTORIS MCK TIBIAL INLAY POLY
- RESTORIS MCK TIBIAL ONLAY INSERT
- RESTORIS TIBIAL ONLAY ANTERIOR CUT REF GUIDE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.