Medical device licence · 77494 · Class 3
SYNFIX-LR SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed July 2, 2008; ended June 28, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 77494
- Licence holder
- Synthes Usa LlcMonument, CO, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 2, 2008
- Ended
- June 28, 2019
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SYNFIX-LR SYSTEM - IMPLANT
- SYNFIX-LR SYSTEM - LOCKING SCREW
- SYNFIX-LR SYSTEM - LOCKING SCREW - FINE TIP
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 “synfix-lr”. A notice may cover another product or only some lots: read it to see what it covers.
- Porte-implant Synfix-LR (2013-11-06)December 4, 2013 · 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.