ApprovalTrail

Medical device licence · 89881 · Class 3

AGILITY LP TOTAL ANKLE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed October 25, 2012. It is in Health Canada’s list of active licences.
Licence number
89881
Licence holder
Depuy Orthopaedics, Inc.Warsaw, IN, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
October 25, 2012
Devices covered
5

Devices on this licence

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

  • AGILITY LP TOTAL ANKLE SYSTEM - +1 POLY INSERT
  • AGILITY LP TOTAL ANKLE SYSTEM - POLY INSERT
  • AGILITY LP TOTAL ANKLE SYSTEM - POLY INSERT MISMATCH
  • AGILITY LP TOTAL ANKLE SYSTEM - TALAR - CEMENTED
  • AGILITY LP TOTAL ANKLE SYSTEM - TIBIAL - CEMENTED

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