Medical device licence · 82578 · Class 3
RESTORATION ADM SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 16, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82578
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 16, 2010
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RESTORATION ADM SYSTEM - ACETABULAR CUP WITH HA, LEFT
- RESTORATION ADM SYSTEM - ACETABULAR CUP WITH HA, RIGHT
- RESTORATION ADM SYSTEM - X3 INSERT
- RESTORATION ADM SYSTEM - X3 INSERT 28
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.