ApprovalTrail

Medical device licence · 83105 · Class 2

KNEE TRIALS - PLASTIC

Yes: licensed in Canada

Licence status Issued (active); first licensed June 21, 2010. It is in Health Canada’s list of active licences.
Licence number
83105
Licence holder
Medacta International SaCastel San Pietro, Switzerland
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
June 21, 2010
Devices covered
14

Devices on this licence

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

  • EVOLIS TIBIAL ULTRA CONGRUENT TRIAL INSERT
  • EVOLIS TRIAL INSERT
  • EVOLIS TRIAL INSERTED PATELLA
  • EVOLIS TRIAL RESURFACING PATELLA
  • FLEX E-CROSS TRIAL INSERT
  • FLEX TRIAL INSERT
  • GMK PRIMARY TRIAL TROCHLEA
  • GMK TRIAL FIXED TIBIAL INSERTS
  • GMK TRIAL INSERT STD MOBILE
  • GMK TRIAL INSERT UC MOBILE
  • GMK TRIAL INSET PATELLA
  • GMK TRIAL RESURFACING PATELLA
  • TRIAL TIBIAL INSERT
  • TRIAL TIBIAL INSERT CR

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