Medical device licence · 89309 · Class 2
IASSIST KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 19, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89309
- Licence holder
- Orthosoft UlcMontreal, QC, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 19, 2012
- Devices covered
- 32
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FEMORAL SPIKE
- HBMI FEMORAL A/P SLIDER
- HBMI FEMORAL DISTAL CUT GUIDE
- IASSIST KNEE SYSTEM - ALIGNMENT ARCH
- IASSIST KNEE SYSTEM - CAS SMALL SPIKE
- IASSIST KNEE SYSTEM - FEMORAL ADJUSTMENT MECHANISM
- IASSIST KNEE SYSTEM - FEMORAL AP SLIDER
- IASSIST KNEE SYSTEM - FEMORAL DISTAL CUT GUIDE
- IASSIST KNEE SYSTEM - FEMORAL REFERENCE
- IASSIST KNEE SYSTEM - FEMORAL SAW SLOT
- IASSIST KNEE SYSTEM - HEADLESS TROCAR DRILL PIN
- IASSIST KNEE SYSTEM - HEX HEAD KNOB
- IASSIST KNEE SYSTEM - HEX HEAD SCREW
- IASSIST KNEE SYSTEM - POD CALIBRATION JIG
- IASSIST KNEE SYSTEM - POD KIT
- IASSIST KNEE SYSTEM - SYSTEM CONTROLLER COMPUTER
- IASSIST KNEE SYSTEM - SYSTEM CONTROLLER POWER SUPPLY
- IASSIST KNEE SYSTEM - TIBIAL ALIGNMENT GUIDE
- IASSIST KNEE SYSTEM - TIBIAL LEFT ADJUSTMENT MECHANISM
- IASSIST KNEE SYSTEM - TIBIAL LEFT CUT GUIDE
- IASSIST KNEE SYSTEM - TIBIAL LEFT POSITIONER
- IASSIST KNEE SYSTEM - TIBIAL RIGHT ADJUSTMENT MECHANISM
- IASSIST KNEE SYSTEM - TIBIAL RIGHT CUT GUIDE
- IASSIST KNEE SYSTEM - TIBIAL RIGHT POSITIONER
- IASSIST KNEE SYSTEM - VALIDATION TOOL
- IASSIST KNEE V2 POD KIT
- IASSIST PIN AND SCREW PACK STERILE
- IASSIST V2 TABLET
- IASSIST V2 TABLET KIT
- IASSIST V2 TABLET POWER SUPPLY
- TIBIAL ALIGNER
- WIRED INTERNET USB ADAPTOR
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “iassist”. A notice may cover another product or only some lots: read it to see what it covers.
- iASSIST Knee System - Validation ToolApril 4, 2017 · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.