Medical device licence · 108243 · Class 3
FIBULA NAIL 2 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 9, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108243
- Licence holder
- Acumed, LlcHillsboro, OR, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 9, 2022
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CORTEX AWL WITH QUICK RELEASE
- FAR CORTEX DRILL
- FEN DRILL
- FEN HEADLESS SCREW COUNTERSINK
- FFN END CAP
- FFN END CAP - STERILE PACKED
- FIBULA NAIL 2
- NEAR CORTEX DRILL
- TIP-LOC BUSHING & SET SCREW KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.