Medical device licence · 97168 · Class 3
RESTORATION ANATOMIC ACETABULAR COMPONENT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 28, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97168
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 28, 2016
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DRILL GUIDE
- RESTORATION ANATOMIC SHELL
- RESTORATION ANATOMIC SHELL TRIAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.