Medical device licence · 109066 · Class 3
SPINAL GUIDANCE SOFTWARE
Yes: licensed in Canada
Licence status Issued (active); first licensed March 15, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109066
- Licence holder
- Stryker Leibinger Gmbh & Co. KgKalamazoo, MI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 15, 2023
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADAPTER - OEC 3D
- CALIBRATION BODY
- MAYFIELD BASE WITH ARTICULATING ARM
- REGISTRATION POINTER
- SPINE GUIDANCE 5 ENABLE
- SPINE GUIDANCE 5 SOFTWARE
- SPINE GUIDANCE 5 UPDATE
- SPINE GUIDANCE 5 UPGRADE
- SPINE GUIDANCE ENABLE
- SPINE GUIDANCE SOFTWARE
- SPINE GUIDANCE UPDATE
- SPINE GUIDANCE UPGRADE
- TRACKER-70
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.