Medical device licence · 98053 · Class 3
SYNFIX EVOLUTION
Yes: licensed in Canada
Licence status Issued (active); first licensed November 21, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 98053
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 21, 2016
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EVOLUTION QUICK INSERTER/DISTRACTOR
- SYNFIX EVO FOOTPRINT TRIAL
- SYNFIX EVO IMPLANT REMOVAL INSTRUMENT
- SYNFIX EVOLUTION AIMING DEVICE
- SYNFIX EVOLUTION AWL WITHOUT SLEEVE
- SYNFIX EVOLUTION FINE TIP SCREW
- SYNFIX EVOLUTION SCREW
- SYNFIX EVOLUTION SPACER LARGE
- SYNFIX EVOLUTION SPACER LG DEEP
- SYNFIX EVOLUTION SPACER MED
- SYNFIX EVOLUTION SPACER MED DEEP
- SYNFIX EVOLUTION SPACER SM DEEP
- SYNFIX EVOLUTION SPACER SMALL
- SYNFIX EVOLUTION THREAD LOCK SLEEVE-STERILE
- SYNFIX EVOLUTION TRIAL SPACER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.