Medical device licence · 12949 · Class 3
UNIVERSAL ACETABULAR COMPONENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed October 6, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 12949
- Licence holder
- Biomet Orthopedics, Ata Biomet Sports Medicine, Ata Biomet Biologics, Ata Biomet TraumaWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- October 6, 1999
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- UNIVERSAL ACETABULAR SHELL SOLID WITH APICAL DOME HOLE
- UNIVERSAL POROUS COATED ACETABULAR SHELL
- UNIVERSAL POROUS COATED ACETABULAR SHELL 2 HOLE W/ APICAL DOME HOLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.