ApprovalTrail

Medical device licence · 24649 · Class 2

KYPHON INTRODUCER SETS

Yes: licensed in Canada

Licence status Issued (active); first licensed October 30, 2000. It is in Health Canada’s list of active licences.
Licence number
24649
Licence holder
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
October 30, 2000
Devices covered
4

Devices on this licence

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

  • KYPHON ADVANCED OSTEO INTRODUCER SYSTEM
  • KYPHON EXPRESS ADVANCED OSTEO INTRODUCER DEVICE
  • KYPHON EXPRESS OSTEO INTRODUCER DEVICE, TROCAR
  • KYPHON OSTEO INTRODUCER SYSTEM

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