ApprovalTrail

Medical device licence · 95363 · Class 3

SCREWS - TITANIUM

Yes: licensed in Canada

Licence status Issued (active); first licensed June 25, 2015. It is in Health Canada’s list of active licences.
Licence number
95363
Licence holder
Synthes GmbhOberdorf, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
June 25, 2015
Devices covered
9

Devices on this licence

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

  • 3.5MM CANN SCREW S.T.SHORT.THRD
  • CORTEX SCREWS (PURE TITANIUM)
  • THRP.HOLLOW SCREW
  • THRP.SOLID SCREW
  • TIT.SHANZ SCREW
  • TITANIUM CANCELLOUS BONE SCREW
  • TITANIUM CANCELLOUS SCREW
  • TITANIUM CORTEX SCREW SELF-TAPPING
  • TITANIUM LOCKING SCREW

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