ApprovalTrail

Medical device licence · 83227 · Class 3

SYNTHES HEADLESS COMPRESSION SCREWS - TITANIUM

Yes: licensed in Canada

Licence status Issued (active); first licensed June 30, 2010. It is in Health Canada’s list of active licences.
Licence number
83227
Licence holder
Synthes GmbhOberdorf, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
June 30, 2010
Devices covered
18

Devices on this licence

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

  • 1.5MM HEADLESS COMPRESSION SCREW (TITANIUM ALLOY) NON STERILE
  • 1.5MM HEADLESS COMPRESSION SCREW, (TITATIUM ALLOY), STERILE
  • 2.4MM HEADLESS COMPRESSION SCREW, CANNULA., SHORT THREAD,(TITANIUM) STERILE
  • 2.4MM HEADLESS COMPRESSION SCREW, CANNULAT., LONG THREAD,(TITANIUM) STERILE
  • 2.4MM HEADLESS COMPRESSION SCREW, CANNULATED, LONG THREAD, (TITANIUM)
  • 2.4MM HEADLESS COMPRESSION SCREW, CANNULATED, SHORT THREAD, (TITANIUM)
  • 3.0MM HEADLESS COMPRESSION SCREW, LONG THREAD, (TITANIUM)
  • 3.0MM HEADLESS COMPRESSION SCREW, LONG THREAD, (TITANIUM) STERILE
  • 3.0MM HEADLESS COMPRESSION SCREW, SHORT THREAD, (TITANIUM)
  • 3.0MM HEADLESS COMPRESSION SCREW, SHORT THREAD, (TITANIUM) STERILE
  • 4.5MM HEADLESS COMPRESSION SCREW, LONG THREAD, (TITANIUM)
  • 4.5MM HEADLESS COMPRESSION SCREW, LONG THREAD, (TITANIUM) STERILE
  • 4.5MM HEADLESS COMPRESSION SCREW, SHORT THREAD, (TITANIUM)
  • 4.5MM HEADLESS COMPRESSION SCREW, SHORT THREAD, (TITANIUM) STERILE
  • 6.5MM HEADLESS COMPRESSION SCREW, 16MM THREAD, (TITANIUM)
  • 6.5MM HEADLESS COMPRESSION SCREW, 16MM THREAD, (TITANIUM) STERILE
  • 6.5MM HEADLESS COMPRESSION SCREW, 32MM THREAD, (TITANIUM)
  • 6.5MM HEADLESS COMPRESSION SCREW, 32MM THREAD, (TITANIUM) STERILE

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