Medical device licence · 92336 · Class 3
DVR CROSSLOCK DISTAL RADIUS PLATING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 21, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 92336
- Licence holder
- Biomet Orthopedics, Ata Biomet Sports Medicine, Ata Biomet Biologics, Ata Biomet TraumaWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 21, 2013
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CORTICAL LOCK SCREW
- DRILL BIT
- DVR CROSSLOCK EPAK DEPTH GAUGE
- DVR CROSSLOCK EPAK PLATE SIZING TEMPLATE SET
- DVR CROSSLOCK EPAK SCREW DRIVER
- DVR CROSSLOCK EPAK SOFT TISSUE GUIDE
- DVR CROSSLOCK PLATES
- DVR CROSSLOCK VOLAR RIM
- EPAK DVR CROSSLOCK DISTAL VOLAR RADIUS PLATE
- KWIRE TROCHAR TIP
- LOCK SCREW SQUARE DRIVE
- LONG DRILL GUIDE
- LONG PLATE BENDER WITH TWO SLOTS
- LOW PROFILE NON LOCK SCREW
- MULTI-DIRECTIONAL SCREW
- SMOOTH PEG
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.