Medical device licence · 97468 · Class 2
PHANTOM K-WIRE
Yes: licensed in Canada
Licence status Issued (active); first licensed August 9, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97468
- Licence holder
- Tedan Surgical Innovations, IncSugar Land, TX, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 9, 2016
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PHANTOM ML K-WIRE
- PHANTOM XL K-WIRE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.