ApprovalTrail

Medical device licence · 80670 · Class 3

VARIAX ELBOW SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed September 17, 2009. It is in Health Canada’s list of active licences.
Licence number
80670
Licence holder
Stryker GmbhSelzach, SO, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
September 17, 2009
Devices covered
29

Devices on this licence

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

  • TAP
  • VARIAX - DISTAL HUMERUS PLATES - NON-STERILE
  • VARIAX - DISTAL HUMERUS PLATES - STERILE
  • VARIAX - OLECRANON PLATES
  • VARIAX - TRIALS
  • VARIAX ELBOW SYSTEM - 2.7 MM DIA BONE SCREWS
  • VARIAX ELBOW SYSTEM - 2.7 MM DIA LOCKING SCREWS
  • VARIAX ELBOW SYSTEM - 3.5 MM DIA BONE SCREWS
  • VARIAX ELBOW SYSTEM - 3.5 MM DIA LOCKING SCREWS
  • VARIAX ELBOW SYSTEM - DISTAL LATERAL HUMERAL PLATE, LEFT
  • VARIAX ELBOW SYSTEM - DISTAL LATERAL HUMERAL PLATE, LEFT, STERILE
  • VARIAX ELBOW SYSTEM - DISTAL LATERAL HUMERAL PLATE, RIGHT
  • VARIAX ELBOW SYSTEM - DISTAL LATERAL HUMERAL PLATE, RIGHT, STERILE
  • VARIAX ELBOW SYSTEM - DISTAL MEDIAL HUMERAL PLATE
  • VARIAX ELBOW SYSTEM - DISTAL MEDIAL HUMERAL PLATE, EXTENDED
  • VARIAX ELBOW SYSTEM - DISTAL MEDIAL HUMERAL PLATE, EXTENDED, STERILE
  • VARIAX ELBOW SYSTEM - DISTAL MEDIAL HUMERAL PLATE, STERILE
  • VARIAX ELBOW SYSTEM - DISTAL POSTERIOR LATERAL HUMERAL PLATE, LEFT
  • VARIAX ELBOW SYSTEM - DISTAL POSTERIOR LATERAL HUMERAL PLATE, LEFT, STERILE
  • VARIAX ELBOW SYSTEM - DISTAL POSTERIOR LATERAL HUMERAL PLATE, RIGHT
  • VARIAX ELBOW SYSTEM - DISTAL POSTERIOR LATERAL HUMERAL PLATE, RIGHT STERILE
  • VARIAX ELBOW SYSTEM - DISTAL POSTERIOR MEDIAL HUMERAL PLATE, LEFT
  • VARIAX ELBOW SYSTEM - DISTAL POSTERIOR MEDIAL HUMERAL PLATE, LEFT, STERILE
  • VARIAX ELBOW SYSTEM - DISTAL POSTERIOR MEDIAL HUMERAL PLATE, RIGHT
  • VARIAX ELBOW SYSTEM - DISTAL POSTERIOR MEDIAL HUMERAL PLATE, RIGHT, STERILE
  • VARIAX ELBOW SYSTEM - OLECRANON PLATE, LEFT
  • VARIAX ELBOW SYSTEM - OLECRANON PLATE, LEFT, STERILE
  • VARIAX ELBOW SYSTEM - OLECRANON PLATE, RIGHT
  • VARIAX ELBOW SYSTEM - OLECRANON PLATE, RIGHT, 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.