ApprovalTrail

Medical device licence · 92675 · Class 3

SIGMA TIBIAL INSERTS - AOX

Yes: licensed in Canada

Licence status Issued (active); first licensed January 28, 2014. It is in Health Canada’s list of active licences.
Licence number
92675
Licence holder
Depuy Orthopaedics, Inc.Warsaw, IN, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
January 28, 2014
Devices covered
3

Devices on this licence

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

  • SIGMA TIBIAL INSERT, ROTATING PLATFORM CURVED
  • SIGMA TIBIAL INSERT, ROTATING PLATFORM RPF
  • SIGMA TIBIAL INSERT, ROTATING PLATFORM STABILIZED

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