Medical device licence · 99956 · Class 2
ORTHOSOFT KNEE UNIVERSAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 2, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99956
- Licence holder
- Orthosoft UlcMontreal, QC, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 2, 2017
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CAS ADAPTOR
- CAS ALL-IN-ONE PADDLES
- CAS CALIBRATION STAR HOLDER
- CAS CONDYLES DIGITIZER
- CAS CUT GUIDES
- CAS CUTTING BLOCK
- CAS DRILL GUIDES
- CAS ELEVATOR
- CAS FIX FLUTED
- CAS FIXATION PINS
- CAS POSITIONING BASE
- CAS REFERENCE PINS
- CAS REGISTRATION POINTERS
- CAS SAME INCISION REFERENCES
- CAS SCREWS
- CAS SPACER
- CAS SPIKES
- CAS STOP DRILL
- CAS TENSOR PADDLES
- CAS VALIDATION TOOL
- NAVITRACKER KIT A: KNEE
- SAW CAPTURE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.