ApprovalTrail

Medical device licence · 105313 · Class 3

VARIAX 2 SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed October 20, 2020. It is in Health Canada’s list of active licences.
Licence number
105313
Licence holder
Stryker GmbhSelzach, SO, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
October 20, 2020
Devices covered
28

Devices on this licence

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

  • VARIAX 2 BONE SCREW - STERILE
  • VARIAX 2 BONE SCREW, T10
  • VARIAX 2 BONE SCREW, T5
  • VARIAX 2 BONE SCREW, T6
  • VARIAX 2 BONE SCREW, T6 (STERILE)
  • VARIAX 2 COUNTERSINK, AO
  • VARIAX 2 DEPTH GAUGE
  • VARIAX 2 DRILL GUIDE FOR 2.0M INDEP. LAG SCREW
  • VARIAX 2 DRILL, AO, SCALED
  • VARIAX 2 EMERG. SCREW, T5
  • VARIAX 2 EMERG. SCREW, T6
  • VARIAX 2 K-WIRE DRILL
  • VARIAX 2 K-WIRE WITH STOP
  • VARIAX 2 LOCKING PEG, T8
  • VARIAX 2 LOCKING SCREW - STERILE
  • VARIAX 2 LOCKING SCREW, T10
  • VARIAX 2 LOCKING SCREW, T5
  • VARIAX 2 LOCKING SCREW, T6
  • VARIAX 2 LOCKING SCREW, T6 (STERILE)
  • VARIAX 2 LOCKING SCREW, T8
  • VARIAX 2 OVERDRILL, AO
  • VARIAX 2 SCREWDRIVER BLADE, T5
  • VARIAX 2 SCREWDRIVER BLADE, T6
  • VARIAX 2 WASHER, T6
  • VARIAX 2 WASHER, T8 & T10 SCREWS
  • VARIAX 2- TAP AO
  • VARIAX DRILL GUIDE, COMP/POLYAXIAL, T6
  • VARIAX2 BONE SCREW, T8

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.