ApprovalTrail

Medical device licence · 36674 · Class 3

RESTORATION MODULAR SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed March 12, 2002; ended January 19, 2004. It is in Health Canada’s archive of licences no longer in force.
Licence number
36674
Licence holder
Howmedica Osteonics CorporationMahwah, NJ, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
March 12, 2002
Ended
January 19, 2004
Devices covered
12

Devices on this licence

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

  • RESTORATION MODULAR HIP SYSTEM - FLUTED DISTAL STEM
  • RESTORATION MODULAR HIP SYSTEM - MILLED PROXIMAL BODY
  • RESTORATION MODULAR HIP SYSTEM - POROUS DISTAL STEM
  • RESTORATION MODULAR SYSTEM - BROACHED PROXIMAL BODY
  • RESTORATION MODULAR SYSTEM - CONICAL PROXIMAL BODY
  • RESTORATION MODULAR SYSTEM - CONICAL/T3 DISTAL STEM
  • TWO PIECE MODULAR HIP STEM SYSTEM - BROACHED PROXIMAL BODY
  • TWO PIECE MODULAR HIP STEM SYSTEM - CONICAL
  • TWO PIECE MODULAR HIP STEM SYSTEM - CONICAL/T3 DISTAL STEM
  • TWO PIECE MODULAR HIP STEM SYSTEM - FLUTED DISTAL STEM
  • TWO PIECE MODULAR HIP STEM SYSTEM - MILLED PROXIMAL BODY
  • TWO PIECE MODULAR HIP STEM SYSTEM - POROUS DISTAL STEM

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