Medical device licence · 89794 · Class 2
ORTHOPAEDIC TRIALS
Yes: licensed in Canada
Licence status Issued (active); first licensed October 2, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89794
- Licence holder
- Stryker GmbhSelzach, SO, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- October 2, 2012
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AXSOS PLATE TRIAL
- AXSOS PLATE TRIAL/SHAFT HOLE LOCATOR
- HAND XXL VOLAR DR TRIAL, NARROW
- TACTYS TRIAL IMPLANT - DISTAL STEM TRIAL
- TACTYS TRIAL IMPLANT - DISTAL SURFACE TRIAL
- TACTYS TRIAL IMPLANT - PROXIMAL STEM TRIAL
- TACTYS TRIAL IMPLANT - PROXIMAL SURFACE TRIAL
- X-FUSE TRIAL IMPLANT AXF-L
- X-FUSE TRIAL IMPLANT AXF-S
- X-FUSE TRIAL IMPLANT AXF-XL
- X-FUSE TRIAL IMPLANT AXF-XS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.