Medical device licence · 62686 · Class 3
TOMOFIX OSTEOTOMY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 13, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 62686
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 13, 2003
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TI TOMOFIX LATERAL DISTAL FEMUR PLATE
- TI TOMOFIX LATERAL DISTAL FEMUR PLATE, STERILE
- TI TOMOFIX LATERAL HIGH TIBIA PLATE
- TI TOMOFIX LATERAL HIGH TIBIA PLATE, STERILE
- TI TOMOFIX MEDIAL DISTAL FEMUR PLATE
- TI TOMOFIX MEDIAL DISTAL FEMUR PLATE, STERILE
- TI TOMOFIX MEDIAL HIGH TIBIA PLATE
- TI TOMOFIX MEDIAL HIGH TIBIA PLATE, STERILE
- TI TOMOFIX SPACER
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 “tomofix”. A notice may cover another product or only some lots: read it to see what it covers.
- Tomofix Technique Guides (2013-10-22)November 29, 2013 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.