Medical device licence · 103535 · Class 2
ROSA RECON PLATFORM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 5, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103535
- Licence holder
- Orthosoft UlcMontreal, QC, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 5, 2019
- Devices covered
- 17
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 CHECKPOINT SCREW
- ROSA KNEE CONDYLE DIGITIZER
- ROSA KNEE TIBIA VALIDATION TOOL
- ROSA NEXGEN TKA CUT GUIDE
- ROSA PERSONA TKA CUT GUIDE
- ROSA PIN STABILIZER, 60MM
- ROSA RECON OPTICAL UNIT
- ROSA RECON PLATFORM 110V
- ROSA RECON ROBOTIC UNIT 110V
- ROSA REGISTRATION POINTER
- ROSA STABILIZER TISSUE DEFLECTOR, 60MM
- ROSA TIBIA REFERENCE A - ROSA KNEE
- ROSA TIBIA REFERENCE B - ROSA KNEE
- ROSA VANGUARD TKA CUT GUIDE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.