Medical device licence · 102085 · Class 3
ACTIS TOTAL HIP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 30, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 102085
- Licence holder
- Depuy Ireland UcRingaskiddy, CK, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 30, 2018
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACTIS BROACH
- ACTIS DUOFIX HIP PROSTHESIS HIGH
- ACTIS DUOFIX HIP PROSTHESIS STD
- ACTIS HIGH NECK
- ACTIS INSERTER SHAFT
- ACTIS NECK RESECTION GUIDE
- ACTIS REAMER
- ACTIS RETAINING STEM INSERTER
- ACTIS STANDARD NECK
- MODULAR CALCAR REAMER SHAFT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.