ApprovalTrail

Medical device licence · 97789 · Class 3

VARIAX 2 FOOT SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed October 5, 2016. It is in Health Canada’s list of active licences.
Licence number
97789
Licence holder
Stryker GmbhSelzach, SO, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
October 5, 2016
Devices covered
26

Devices on this licence

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

  • POLYAXIAL LOCKING PLATE CUBOID
  • POLYAXIAL LOCKING PLATE CUBOID (STERILE)
  • POLYAXIAL LOCKING PLATE LATERAL COLUMN LENGTHENING
  • POLYAXIAL LOCKING PLATE LATERAL COLUMN LENGTHENING (STERILE)
  • POLYAXIAL LOCKING PLATE MEDIAL COLUMN FUSION
  • POLYAXIAL LOCKING PLATE MEDIAL COLUMN FUSION (STERILE)
  • POLYAXIAL LOCKING PLATE NAVICULAR
  • POLYAXIAL LOCKING PLATE NAVICULAR (STERILE)
  • POLYAXIAL LOCKING PLATE NAVICULAR-CUNEIFORM
  • POLYAXIAL LOCKING PLATE NAVICULAR-CUNEIFORM (STERILE)
  • POLYAXIAL LOCKING PLATE TALAR NECK
  • POLYAXIAL LOCKING PLATE TALAR NECK (STERILE)
  • POLYAXIAL LOCKING PLATE TALO-NAVICULAR
  • POLYAXIAL LOCKING PLATE TALO-NAVICULAR (STERILE)
  • VARIAX 2 BONE SCREW - STERILE
  • VARIAX 2 BONE SCREWS - NON-STERILE
  • VARIAX 2 FOOT BROAD STRAIGHT PLATE
  • VARIAX 2 FOOT BROAD Y-PLATE
  • VARIAX 2 FOOT SLIM STRAIGHT PLATE
  • VARIAX 2 FOOT SLIM Y-PLATE PLATE
  • VARIAX 2 LOCKING SCREW - NON-STERILE
  • VARIAX 2 LOCKING SCREW - STERILE
  • VARIAX 2 LOCKING SCREWS - T8 STERILE
  • VARIAX 2 T8 BONE SCREW - NON STERILE
  • VARIAX 2 T8 BONE SCREW - STERILE
  • VARIAX 2 T8 LOCKING PEG - NON-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.