ApprovalTrail

Medical device licence · 12788 · Class 3

TITANIUM ALLOY NAILS

Yes: licensed in Canada

Licence status Issued (active); first licensed October 1, 1999. It is in Health Canada’s list of active licences.
Licence number
12788
Licence holder
Synthes GmbhOberdorf, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
October 1, 1999
Devices covered
16

Devices on this licence

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

  • TI LOCKING END CAP
  • TI PROXIMAL HUMERAL NAIL
  • TI.SPIRAL BLADE
  • TI.UNREAM.FEM.NAIL
  • TITANIUM CANNULATED FERMORAL NAIL
  • TITANIUM CANNULATED TIBIAL NAIL
  • TITANIUM END CAPS
  • TITANIUM HELICAL BLADE
  • TITANIUM HUMERAL NAIL
  • TITANIUM LOCKING BOLT
  • TITANIUM LOCKING SCREW
  • TITANIUM LOCKING SCREW
  • TITANIUM PROXIMAL HUMERAL NAIL
  • TITANIUM TROCHANTERIC FIXATION NAIL
  • TITANIUM TROCHANTERIC FIXATION NAIL - LEFT
  • TITANIUM TROCHANTERIC FIXATION NAIL - RIGHT

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