ApprovalTrail

Medical device licence · 100989 · Class 2

PHANTOM K-WIRE SHIM

Yes: licensed in Canada

Licence status Issued (active); first licensed May 8, 2018. It is in Health Canada’s list of active licences.
Licence number
100989
Licence holder
Tedan Surgical Innovations, IncSugar Land, TX, United States
Risk class
Class II (low to moderate risk)
Licence type
Single Device
First licensed
May 8, 2018
Devices covered
1

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • PHANTOM XL K-WIRE SHIM, SINGLE USE

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.