Medical device licence · 112448 · Class 2
SKYWALKER TOTAL KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 20, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 112448
- Licence holder
- Microport Navibot International LlcArlington, TN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 20, 2024
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DRAPE
- KNEE KIT
- KNEE TRAY
- LEG POSITIONER
- LONG PIN
- LONG PIN-NAIL KIT
- MARKER BOX
- NAIL
- NAVIGATION CONSOLE
- STANDARD PIN
- STANDARD PIN-NAIL KIT
- SURGICAL CONSOLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.