Medical device licence · 108181 · Class 3
INSIGNIA HIP STEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 17, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108181
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 17, 2022
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INSIGNIA HIP STEM - HIGH OFFSET
- INSIGNIA HIP STEM - STANDARD OFFSET
- INSIGNIA HIP STEM BROACH
- INSIGNIA HIP STEM HIGH NECK TRIAL
- INSIGNIA HIP STEM STANDARD NECK TRIAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.