Medical device licence · 92010 · Class 3
FIXOS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 27, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 92010
- Licence holder
- Stryker GmbhSelzach, SO, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 27, 2013
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FIXOS - CANNULATED COMPRESSION SCREW
- FIXOS - TWIST-OFF SCREW
- FIXOS CANNULATED COUNTERSINK
- FIXOS CANNULATED DRILL
- FIXOS CANNULATED SCREWDRIVER, AO FITTING
- FIXOS CANNULATED TAP
- FIXOS DIRECT MEASURING GAUGE FOR WIRES
- FIXOS DOUBLE DRILL GUIDE
- FIXOS DRILL BITS
- FIXOS GUIDE WIRE
- FIXOS HEADLESS COMPRESSION SCREWS
- FIXOS HEADLESS COMPRESSION SCREWS - STERILE
- FIXOS SCREWDRIVER BIT
- FIXOS SOLID SCREWDRIVER, AO FITTING
- KIRSCHNER WIRE
- KIRSCHNER WIRE (10/PACKAGE)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.