ApprovalTrail

Medical device licence · 88863 · Class 3

ZENIUS SPINAL SYSTEM

No longer licensed: cancelled: renewal not answered

Licence status Cancelled: renewal not answered; first licensed May 15, 2012; ended October 31, 2018. It is in Health Canada’s archive of licences no longer in force.
Licence number
88863
Licence holder
Medyssey Co. Ltd.Jecheon-Si, South Korea
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
May 15, 2012
Ended
October 31, 2018
Devices covered
17

Devices on this licence

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

  • ZENIUS SPINAL SYSTEM - BLOCK
  • ZENIUS SPINAL SYSTEM - CANNULATED MONO AXIAL PEDICLE SCREW
  • ZENIUS SPINAL SYSTEM - CANNULATED POLY AXIAL PEDICLE SCREW
  • ZENIUS SPINAL SYSTEM - CONNECTOR
  • ZENIUS SPINAL SYSTEM - CROSS LINK
  • ZENIUS SPINAL SYSTEM - GUIDE MONO AXIAL PEDICLE SCREW
  • ZENIUS SPINAL SYSTEM - GUIDE POLY AXIAL PEDICLE SCREW
  • ZENIUS SPINAL SYSTEM - HOOK
  • ZENIUS SPINAL SYSTEM - MONO AXIAL ILIAC SCREW
  • ZENIUS SPINAL SYSTEM - MONO AXIAL PEDICLE SCREW
  • ZENIUS SPINAL SYSTEM - POLY AXIAL ILIAC SCREW
  • ZENIUS SPINAL SYSTEM - POLY AXIAL PEDICLE SCREW
  • ZENIUS SPINAL SYSTEM - PRE-BENDING ROD
  • ZENIUS SPINAL SYSTEM - REDUCTION MONO AIAL PEDICLE SCREW
  • ZENIUS SPINAL SYSTEM - REDUCTION POLY AXIA PEDICLE SCREW
  • ZENIUS SPINAL SYSTEM - ROD
  • ZENIUS SPINAL SYSTEM - SET SCREW

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