Medical device licence · 112985 · Class 2
ROSA PARTIAL KNEE
Yes: licensed in Canada
Licence status Issued (active); first licensed March 28, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 112985
- Licence holder
- Orthosoft UlcMontreal, QC, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 28, 2025
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ROSA ARM INSTRUMENT INTERFACE
- ROSA ARM REFERENCE FRAME
- ROSA BASE REFERENCE FRAME
- ROSA PERSONA PK MEDIAL CUT GUIDE A-LEFT
- ROSA PERSONA PK MEDIAL CUT GUIDE A-RIGHT
- ROSA PERSONA PK MEDIAL CUT GUIDE B-LEFT
- ROSA PERSONA PK MEDIAL CUT GUIDE B-RIGHT
- ROSA PKA VALIDATION TOOL
- ROSA RECON OPTICAL UNIT
- ROSA RECON ROBOTIC UNIT 110V
- ROSA REGISTRATION POINTER
- ROSA TIBIA REFERENCE A - ROSA KNEE
- ROSA TIBIA REFERENCE B - ROSA KNEE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.