ApprovalTrail

Medical device licence · 106598 · Class 3

CIRQ ALIGNMENT SPINE

Yes: licensed in Canada

Licence status Issued (active); first licensed September 3, 2021. It is in Health Canada’s list of active licences.
Licence number
106598
Licence holder
Brainlab SeMunich, Germany
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
September 3, 2021
Devices covered
13

Devices on this licence

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

  • ALIGNMENT GUIDE TUBE SPINE
  • ALIGNMENT SOFTWARE SPINE
  • ALIGNMENT TROCAR SPINE
  • CIRQ INSTRUMENT HOLDER FOR SPINAL DRILLING
  • CIRQ ROBOTIC ALIGNMENT MODULE
  • CIRQ ROBOTIC ALIGNMENT SOFTWARE
  • CIRQ ROBOTIC BIOPSY BONE ANCHOR CRANIAL
  • CIRQ ROBOTIC BIOPSY DRILL BIT 3.4 CRANIAL
  • CIRQ ROBOTIC BIOPSY GUIDE TUBE CRANIAL
  • CIRQ ROBOTIC DISPOSABLE KINEMATIC UNIT
  • CRANIAL NAVIGATION
  • NAVIGATION SOFTWARE ENT
  • NAVIGATION SOFTWARE SPINE & TRAUMA 3D

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