Medical device licence · 12557 · Class 3
BONE VOID FILLER
Yes: licensed in Canada
Licence status Issued (active); first licensed September 27, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 12557
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- September 27, 1999
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NORIAN DRILLABLE FAST SET PUTTY
- NORIAN DRILLABLE, CALCIUM PHOSPHATE BONE VOID FILLER
- NORIAN SRS - SKELETAL REPAIR SYSTEM CEMENT
- NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.