Medical device licence · 64065 · Class 3
SYSTEM 12 - CROSSFIRE POLYETHYLENE ACETABULAR INSERTS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 31, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 64065
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- March 31, 2004
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SYSTEM 12 - CROSSFIRE POLYETHYLENE ACETABULAR INSERT - 28MM
- SYSTEM 12 - CROSSFIRE POLYETHYLENE ACETABULAR INSERT - 32MM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.