ApprovalTrail

Medical device licence · 74819 · Class 3

PEEK SPINAL SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed September 5, 2007. It is in Health Canada’s list of active licences.
Licence number
74819
Licence holder
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
September 5, 2007
Devices covered
4

Devices on this licence

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

  • CAPSTONE PEEK SYSTEM
  • CLYDESDALE PEEK SYSTEM
  • NAV TRIAL, CAPSTONE
  • PERIMETER INTERBODY FUSION DEVICE INTERBODY SPACER

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