ApprovalTrail

Medical device licence · 12625 · Class 3

AGILITY ANKLE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed September 28, 1999. It is in Health Canada’s list of active licences.
Licence number
12625
Licence holder
Depuy Orthopaedics, Inc.Warsaw, IN, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
September 28, 1999
Devices covered
3

Devices on this licence

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

  • AGILITY ANKLE REVISED TALAR COMPONENT
  • AGILITY ANKLE SYSTEM - POSTERIOR AUGMENTED TALAR COMPONENT
  • AGILITY ANKLE SYSTEM - TIBIAL (METAL SHELL)

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