ApprovalTrail

Medical device licence · 87614 · Class 3

AVANTAGE (ACETABULUM SYSTEM)

Yes: licensed in Canada

Licence status Issued (active); first licensed November 15, 2011. It is in Health Canada’s list of active licences.
Licence number
87614
Licence holder
Biomet Uk LimitedBridgend, United Kingdom
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
November 15, 2011
Devices covered
18

Devices on this licence

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

  • AVANTAGE 3P ACETABULAR CUP PLASMA TI HA
  • AVANTAGE CEMENTED ACETABULAR CUP
  • AVANTAGE CUP POSITIONER V3
  • AVANTAGE E1 INSERT
  • AVANTAGE FINAL ORIENTATION/IMPACTION TIP
  • AVANTAGE HEAD/LINER PUSHER TIP
  • AVANTAGE IMPACTOR TIP
  • AVANTAGE INSERT
  • AVANTAGE INSERT PRESS
  • AVANTAGE INSTRUMENTATION
  • AVANTAGE PEG SHAPER
  • AVANTAGE PIN
  • AVANTAGE RELOAD ACETABULAR CUP
  • AVANTAGE REVISION PLATE
  • AVANTAGE SCREW
  • AVANTAGE TRIAL CUP
  • AVANTAGE TRIAL CUP POSITIONER
  • AVANTAGE TRIAL INSERT

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 “avantage”. 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.