Medical device licence · 99446 · Class 3
OSS SIDE ACCESS EXPANDABLE DEVICE
Yes: licensed in Canada
Licence status Issued (active); first licensed July 26, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99446
- 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
- July 26, 2017
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) - DISTAL FEMORAL SIDE ACCESS EXPANDABLE - REDUCED SIZE
- SIDE ACCESS EXPANDABLE MODULAR BALL HEX
- SIDE ACCESS EXPANDABLE MODULAR STRAIGHT HEX
- SIDE ACCESS EXPANDABLE REVOLUTION COUNTER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.