ApprovalTrail

Medical device licence · 100908 · Class 2

GMK EFFICIENCY INSTRUMENTS

Yes: licensed in Canada

Licence status Issued (active); first licensed April 23, 2018. It is in Health Canada’s list of active licences.
Licence number
100908
Licence holder
Medacta International SaCastel San Pietro, Switzerland
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
April 23, 2018
Devices covered
30

Devices on this licence

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

  • CALIPERS
  • CONVENTIONAL INSTRUMENT SET
  • CONVENTIONAL KA LINK DEVICE SET
  • CONVENTIONAL SET
  • EXTENSION INSTRUMENT SET
  • GMK PRIMARY - FEMORAL SET
  • GMK PRIMARY - GENERAL MIS SET
  • GMK PRIMARY - GENERAL SET
  • GMK PRIMARY - INSERT SET
  • GMK PRIMARY - TIBIAL SET
  • GMK PRIMARY DRILLS AND REAMERS PS
  • GMK SPHERE - FEMORAL SET
  • GMK SPHERE - GENERAL MIS SET
  • GMK SPHERE - GENERAL SET
  • GMK SPHERE - INSERT SET
  • GMK SPHERE DRILLS AND REAMERS
  • GMK SPHERE GMK 3D METAL BASEPLATE TIBIAL SET
  • GMK SPHERE TIBIAL SET
  • GMK SPHERIKA FEMORAL SET
  • LONG THREADED PINS PACK
  • MOTORIZED SCREW DRIVER
  • PATELLA INSTRUMENT SET
  • PIN ADAPTER
  • RECUT GUIDES TYPE MIS
  • RECUT GUIDES TYPE STD
  • SCREWS PACK
  • SHORT THREADED PINS PACK
  • SMOOTH PINS PACK + DRILL BIT
  • SMOOTH SWORD PINS PACK
  • WASHERS AND SHIMS

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