Medical device licence · 91974 · Class 3
XRL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 18, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91974
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 18, 2013
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- XRL ENDPLATE SCREWS
- XRL LARGE CENTRAL BODY
- XRL LARGE ENDPLATE
- XRL LARGE IMPLANT
- XRL MEDIUM CENTRAL BODY
- XRL MEDIUM ENDPLATE
- XRL MEDIUM IMPLANT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.