Medical device licence · 66500 · Class 3
MANDIBLE EXTERNAL FIXATOR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 22, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 66500
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 22, 2004
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MANDIBLE EXTERNAL FIXATOR SYSTEM - ADJUSTABLE CLAMP
- MANDIBLE EXTERNAL FIXATOR SYSTEM - CARBON FIBER ROD
- MANDIBLE EXTERNAL FIXATOR SYSTEM - KIRSCHNER WIRE
- MANDIBLE EXTERNAL FIXATOR SYSTEM - MANDIBLE ROD
- MANDIBLE EXTERNAL FIXATOR SYSTEM - SCHANZ SCREW
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “mandible”. A notice may cover another product or only some lots: read it to see what it covers.
- CMF Distraction System - Mandible Cloverleaf Foot, AB & BC Craniofacial Distractor Body (2019-11-28)January 10, 2020 · Medical devices · Medical devices · Type III
- Various Devices of Mandible External Fixator System (2014-10-09)November 7, 2014 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.