ApprovalTrail

Medical device licence · 19594 · Class 3

AML TOTAL HIP SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed April 13, 2000. It is in Health Canada’s list of active licences.
Licence number
19594
Licence holder
Depuy (Ireland)Ringaskiddy, CK, Ireland
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
April 13, 2000
Devices covered
6

Devices on this licence

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

  • AML LARGE STATURE HIP STEM
  • AML MODULAR HEAD TOTAL HIP SYSTEM
  • AML SMALL STATURE HIP STEM
  • BANTAM HIP FEMORAL STEM (ORTHROCHROME)
  • BANTAM HIP FEMORAL STEM (TITANIUM)
  • BANTAM MODIFIED MODULAR HEAD

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