ApprovalTrail

Medical device licence · 38756 · Class 3

NEXGEN COMPLETE KNEE SOLUTION - ROTATING HINGE KNEE

Yes: licensed in Canada

Licence status Issued (active); first licensed June 6, 2002. It is in Health Canada’s list of active licences.
Licence number
38756
Licence holder
Zimmer Inc.Winterthur, SZ, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
June 6, 2002
Devices covered
11

Devices on this licence

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

  • NEXGEN ROTATING HINGE KNEE - ARTICULAR SURFACE COMPONENT
  • NEXGEN ROTATING HINGE KNEE - ARTICULAR SURFACE COMPONENTS, SIZE B
  • NEXGEN ROTATING HINGE KNEE - DRILL GUIDE
  • NEXGEN ROTATING HINGE KNEE - FEMORAL AUGMENTS
  • NEXGEN ROTATING HINGE KNEE - FEMORAL COMPONENT
  • NEXGEN ROTATING HINGE KNEE - FEMORAL COMPONENTS, SIZE B
  • NEXGEN ROTATING HINGE KNEE - FEMORAL NOTCH/CHAMFER GUIDES
  • NEXGEN ROTATING HINGE KNEE - HAND RASP
  • NEXGEN ROTATING HINGE KNEE - TIBIAL BASEPLATE-FULL BOCK AUGMENTS
  • NEXGEN ROTATING HINGE KNEE - TIBIAL COMPONENT
  • NEXGEN ROTATING HINGE KNEE - TIBIAL PLATE, NON-MODULAR, PMMA

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