ApprovalTrail

Medical device licence · 104628 · Class 3

FINE OSTEOTOMY

Yes: licensed in Canada

Licence status Issued (active); first licensed May 9, 2020. It is in Health Canada’s list of active licences.
Licence number
104628
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
May 9, 2020
Devices covered
13

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • CANCELLOUS COMPRESSION SCREW
  • COMPRESSION CORTICAL BONE SCREW T20
  • CORTICAL COMPRESSION SCREW
  • FINE OSTEOTOMY DISPOSABLE INSTRUMENTS - DISTAL FEMUR
  • FINE OSTEOTOMY DISPOSABLE INSTRUMENTS - PROXIMAL TIBIA
  • FINE OSTEOTOMY IMPLANTS - DISTAL FEMUR
  • FINE OSTEOTOMY IMPLANTS - PROXIMAL TIBIA
  • FINE OSTEOTOMY SYSTEM - DISTAL FEMUR
  • FINE OSTEOTOMY SYSTEM - PROXIMAL TIBIA
  • HA 4.5 CORTICAL COMPRESSION SCREW
  • HA 4.5 CORTICAL LOCKING SCREW
  • HB 6.5 CANCELLOUS COMPRESSION SCREW
  • LOCKING SCREW

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.