ApprovalTrail

Medical device licence · 11882 · Class 3

HTR (HARD TISSUE REPLACEMENT) CRANIOFACIAL RECONSTRUCTIVE IMPLANTS

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed September 15, 1999; ended October 31, 2000. It is in Health Canada’s archive of licences no longer in force.
Licence number
11882
Licence holder
Biomet MicrofixationJacksonville, FL, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
September 15, 1999
Ended
October 31, 2000
Devices covered
8

Devices on this licence

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

  • HTR-MFI CHIN IMPLANT
  • HTR-MFI MALAR IMPLANT
  • HTR-MFI PARANASAL IMPLANT
  • HTR-MFI PREMAXILLARY IMPLANT
  • HTR-MFI RAMUS IMPLANT
  • HTR-MPI FACIAL IMPLANT
  • HTR-MX CURVED BLOCK IMPLANT
  • HTR-MX STRAIGHT BLOCK IMPLANT

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