ApprovalTrail

Medical device licence · 97805 · Class 3

VARIAX 2 COMPRESSION PLATING SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed October 11, 2016. It is in Health Canada’s list of active licences.
Licence number
97805
Licence holder
Stryker GmbhSelzach, SO, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
October 11, 2016
Devices covered
12

Devices on this licence

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

  • DEPTH GAUGE
  • DRILL GUIDE
  • DRILLS
  • VARIAX 2 COMPRESSION PLATE BROAD CURVED - NON STERILE
  • VARIAX 2 COMPRESSION PLATE BROAD CURVED - STERILE
  • VARIAX 2 COMPRESSION PLATE BROAD STRAIGHT - NON STERILE
  • VARIAX 2 COMPRESSION PLATES BROAD STRAIGHT - STERILE
  • VARIAX 2 COMPRESSION PLATES NARROW - NON STERILE
  • VARIAX 2 COMPRESSION PLATES NARROW - SINGLE
  • VARIAX 2 PLATE TRIALS
  • VARIAX 2 WASHER - NON-STERILE
  • VARIAX 2 WASHER - STERILE

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “variax”. A notice may cover another product or only some lots: read it to see what it covers.

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