ApprovalTrail

Medical device licence · 82651 · Class 3

SYNTHES SYNAPSE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed April 23, 2010. It is in Health Canada’s list of active licences.
Licence number
82651
Licence holder
Synthes GmbhOberdorf, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
April 23, 2010
Devices covered
16

Devices on this licence

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

  • ANGLED TI TRANSVERSE BAR
  • SYNAPSE SYSTEM - 3.55MM TI CANCELLOUS POLYAXIAL SCREW
  • SYNAPSE SYSTEM - 3.5MM TI CORTEX POLYAXIAL SHAFT SCREW
  • SYNAPSE SYSTEM - 4.0MM TI CANCELLOUS POLYAXIAL SCREW
  • SYNAPSE SYSTEM - 4.55MM TI CANCELLOUS POLYAXIAL SCREW
  • SYNAPSE SYSTEM - ANGLED TI TOP LOADING TRANSCONNECTOR
  • SYNAPSE SYSTEM - LOCKING NUT
  • SYNAPSE SYSTEM - OPEN TRANSVERSE BAR
  • SYNAPSE SYSTEM - PARALLEL ROD CONNECTOR
  • SYNAPSE SYSTEM - TAPERED RODS
  • SYNAPSE SYSTEM - TI CURVED ROD
  • SYNAPSE SYSTEM - TI ROD
  • SYNAPSE SYSTEM - TI TOP LOADING TRANSCONNECTOR
  • SYNAPSE SYSTEM - TRANSCONNECTOR LOCKING SCREW
  • SYNAPSE SYSTEM - TRANSCONNECTOR, VARIABLE AXIS
  • TI TAPERED ROD

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