ApprovalTrail

Medical device licence · 64096 · Class 3

SIGMA KNEE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed March 31, 2004. It is in Health Canada’s list of active licences.
Licence number
64096
Licence holder
Depuy Orthopaedics, Inc.Warsaw, IN, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
March 31, 2004
Devices covered
10

Devices on this licence

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

  • SIGMA CURVED INSERT - GVF
  • SIGMA CURVED INSERT - XLK
  • SIGMA FEMORAL CRUCIATE RETAINING POROCOAT
  • SIGMA MODULAR TIBIAL TRAY CEMENTED CO-CR
  • SIGMA PLI INSERT
  • SIGMA PLI INSERT - GVF
  • SIGMA POSTERIOR STABILIZED FEMUR
  • SIGMA POSTERIOR STABILIZED LUGGED FEMUR
  • SIGMA STABILIZED INSERT - GVF
  • SIGMA STABILIZED INSERT - XLK

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