ApprovalTrail

Medical device licence · 34702 · Class 3

BONE PLATES - TITANIUM

Yes: licensed in Canada

Licence status Issued (active); first licensed December 10, 2001. It is in Health Canada’s list of active licences.
Licence number
34702
Licence holder
Biomet MicrofixationJacksonville, FL, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
December 10, 2001
Devices covered
31

Devices on this licence

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

  • 1.0 MM PLATE
  • 1.5 MM PLATE
  • 2.0 MM PLATE
  • ADD-ON CONDYLAR PLATE
  • ADD-ON PLATE
  • DOUBLE ROW LEFORT PLATE
  • FRACTURE PLATES
  • LOCKING RECON PLATE
  • ORBITAL HX1.5 CURVED PLATE
  • ORBITAL HX1.5 PLATE
  • PLATE 1.5 MM HX STRAIGHT PLATE
  • PLATE CRVD MATRIX, 1.0 MM
  • PLATE STR W/GAP, 1.0 MM
  • PLATE WITH GAP, 2.0 MM
  • PLATE WITH GAP, 2.0 MM
  • PLATE, ANGLED, 1.6 MM
  • PLATE, ANGLED, 2.0 MM
  • PLATE, ANGLED, 2.6 MM
  • PLATE, CRVD, 1.0MM
  • PLATE, CURVED, 1.6 MM
  • PLATE, LNG Y
  • PLATE, RGD 1.5
  • PLATE, RGD 1.5 CRVD
  • PLATE, STR MATRIX, 1.0 MM
  • PLATE, STR W/GAP, 1.6 MM
  • PLATE, STR W/LONG GAP, 1.0 MM
  • PLATE, STR, 1.0 MM
  • PLATE, STR, 2.0 MM
  • PLATE, STRAIGHT, 1.6 MM
  • SMALL FRAGMENT PLATE
  • STERALOCK PLATE

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