ApprovalTrail

Medical device licence · 62437 · Class 3

RESTORATION HIP SYSTEM

No longer licensed: cancelled

Licence status Cancelled; first licensed May 9, 2003; ended January 31, 2023. It is in Health Canada’s archive of licences no longer in force.
Licence number
62437
Licence holder
Howmedica Osteonics CorporationMahwah, NJ, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
May 9, 2003
Ended
January 31, 2023
Devices covered
6

Devices on this licence

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

  • RESTORATION HIP SYSTEM - BOWED DISTAL STEM
  • RESTORATION HIP SYSTEM - NEUTRAL STEM, 165MM
  • RESTORATION HIP SYSTEM - PS BOWED STEMS
  • RESTORATION HIP SYSTEM - PS LONG STEMS TOTAL HIP
  • RESTORATION HIP SYSTEM - REVISION DISTAL STEM
  • RESTORATION HIP SYSTEM - TITANIUM STEM EXTENSIONS

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