Medical device licence · 72441 · Class 3
CMF DISTRACTION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 3, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 72441
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 3, 2006
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CMF DISTRACTION SYSTEM - AB CRANIOFACIAL DISTRACTOR BODY
- CMF DISTRACTION SYSTEM - BC CRANIOFACIAL DISTRACTOR BODY
- CMF DISTRACTION SYSTEM - MACHINE SCREW FOR CRANIOFACIAL DISTRACTOR
- CMF DISTRACTION SYSTEM - MANDIBLE CLOVERLEAF FOOT
- CMF DISTRACTION SYSTEM - MANDIBLE ELEVATED MESH FOOT
- CMF DISTRACTION SYSTEM - MANDIBLE MESH FOOT
- CMF DISTRACTION SYSTEM - REMOVABLE END CAP
- CMF DISTRACTION SYSTEM - REMOVABLE EXTENSION ARM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.