ApprovalTrail

Medical device licence · 15267 · Class 3

OSTEONICS ABC SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed December 29, 1999. It is in Health Canada’s list of active licences.
Licence number
15267
Licence holder
Howmedica Osteonics CorporationMahwah, NJ, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
December 29, 1999
Devices covered
2

Devices on this licence

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

  • OSTENICS ABC SYSTEM-ALUMINA ACETABULAR INSERTS
  • OSTEONICS ABC SYSTEM-ALUMINA FEMORAL BEARING

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