Medical device licence · 13363 · Class 3
UNITRAX MODULAR ENDOPROSTHESIS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 3, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 13363
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 3, 2000
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
- UNITRAX UNIPOLAR HEADS
- UNITRAX UNIPOLAR NECK ADJUSTMENT SLEEVE
- UNITRAX V40 SLEEVE COMPONENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.