Medical device licence · 97744 · Class 3
RIBFIX BLU SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 4, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97744
- Licence holder
- Biomet MicrofixationJacksonville, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 4, 2016
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RIBFIX BLU - PRE-BENT PLATE
- RIBFIX BLU - STRAIGHT PLATE
- RIBFIX BLU SCREW, EMERGENCY, CANCELLOUS X-DRIVE, LOCKING
- RIBFIX BLU SCREW, SELF-DRILLING, CANCELLOUS X-DRIVE LOCKING
- RIBFIX BLU SCREW, SELF-TAPPING, CANCELLOUS X-DRIVE LOCKING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.