ApprovalTrail

Medical device licence · 14790 · Class 3

SCREWS - TITANIUM ALLOY

Yes: licensed in Canada

Licence status Issued (active); first licensed December 2, 1999. It is in Health Canada’s list of active licences.
Licence number
14790
Licence holder
Synthes GmbhOberdorf, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
December 2, 1999
Devices covered
31

Devices on this licence

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

  • 1.5MM TI CORTEX SCREW S.D.
  • 1.5MM TI CORTEX SCREW SELF-TAPPING
  • 2.0MM TI CORTEX SCREW SELF-TAPPING W/STARDRIVE RECESS
  • 2.7MM TI LOCKING SCREWS, SELF-TAPPING WITH STARDRIVE RECESS
  • 3.0 MM HEADLESS COMPRESSION SCREW
  • 3.0 MM LOCKING SCREW, 12MM, HEX DRIVE
  • 3.0MM TI CANNULATED SCREW, SHORT THREAD
  • 4MM TI CANNULATED SCREW SHORT THREAD
  • 6.5MM TITANIUM CANNULATED SCREW
  • 7.3MM CANNULATED SCREW
  • CANNULATED SCREW
  • CRANIAL MACHINE SCREW
  • SET SCREW FOR TITANIUM TROCHANTERIC FIXATION NAIL - STERILE
  • TI 3.5MM CORTEX SCREW - SELF-TAPPING
  • TI 3.5MM CORTEX SCREW - SELF-TAPPING - SELF-HOLDING
  • TI CORTEX SCREW, SELF-DRILLING
  • TI CORTEX SCREW, SELF-DRILLING, WITH PLUSDRIVE RECESS
  • TI CORTEX SCREW, SELF-TAPPING, PLUSDRIVE
  • TI CORTEX SCREW, SELF-TAPPING, WITH PLUSDRIVE RECESS
  • TI CORTEX SCREW/SELF-DRILLING WITH STARDRIVE RECESS
  • TI CRANIAL SCREW/SELF-DRILLING W/STARDRIVE RECESS
  • TI EMERGENCY SCREW WITH STARDRIVE RECESS
  • TI EMERGENCY SCREW, PLUSDRIVE
  • TI EMERGENCY SCREW, SELF-TAPPING, PLUSDRIVE
  • TI MATRIXMIDFACE EMERGENCY SCREW
  • TI MATRIXMIDFACE SCREW SELF-DRILLING
  • TI MATRIXMIDFACE SCREW SELF-TAPPING
  • TI TROCHANTERIC FIXATION NAIL SCREW
  • TI TROCHANTERIC FIXATION NAIL SCREW, STERILE
  • TITANIUM K-WIRE
  • TITANIUM THREADED WASHER

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