Medical device licence · 105771 · Class 3
EMPHASYS HIP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 29, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105771
- Licence holder
- Depuy Ireland UcRingaskiddy, CK, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 29, 2021
- Devices covered
- 23
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALCAR PLANER
- CANAL PROBE, CURVED
- CANAL PROBE, STRAIGHT
- EMPHASYS ACETABULAR SHELL 3HOLE
- EMPHASYS ACETABULAR SHELL MULTIHOLE
- EMPHASYS ACETABULAR SHELL NO-HOLE
- EMPHASYS FEMORAL BROACH
- EMPHASYS FEMORAL BROACH EXTRACTOR
- EMPHASYS FEMORAL BROACH STARTER
- EMPHASYS FEMORAL STEAM COLLARED HIGH OFFSET
- EMPHASYS FEMORAL STEAM COLLARED STANDARD OFFSET
- EMPHASYS FEMORAL STEAM COLLARLESS HIGH OFFSET
- EMPHASYS FEMORAL STEAM COLLARLESS STANDARD OFFSET
- EMPHASYS POLYETHYLENE LINER
- EMPHASYS TRIAL LINER
- EMPHASYS TRIAL NECK STANDARD OFFSET
- EMPHASYS TRIAL SHELL
- NECK RESECTION GUIDE
- STEM EXTRACTOR, OFFSET ADAPTOR
- STEM EXTRACTOR, OFFSET ADAPTOR RETAINER
- STEM EXTRACTOR, SHAFT
- STEM EXTRACTOR, SLAP HAMMER
- TRIAL HEAD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.