ApprovalTrail

Medical device licence · 84411 · Class 2

NAVIGATED SPINE INSTRUMENTS

Yes: licensed in Canada

Licence status Issued (active); first licensed November 10, 2010. It is in Health Canada’s list of active licences.
Licence number
84411
Licence holder
Stryker SpineAllendale, NJ, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
November 10, 2010
Devices covered
10

Devices on this licence

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

  • AWL
  • INSTRUMENT, CALIBRATION
  • MODULAR TAP
  • NAVIGATED MANTIS CANNULATED AWL
  • NAVIGATED MANTIS CANNULATED TAP
  • NAVIGATED XIA 3 AWL TAP
  • NAVIGATED XIA POLYAXIAL SCREWDRIVER
  • PROBE, BLUNT, STRAIGHT
  • PROBE, THORACIC, STRAIGHT
  • SCREWDRIVER, POLYAXIAL

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