Medical device licence · 98796 · Class 3
FRAGMENT PLATES
Yes: licensed in Canada
Licence status Issued (active); first licensed March 10, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98796
- Licence holder
- Acumed, LlcHillsboro, OR, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 10, 2017
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DEPTH GAUGE
- DRILL GUIDE
- FRAGMENT PLATE
- FRAGMENT PLATE BENDER
- FRAGMENT PLATE CUTTER
- FRAGMENT PLATE TRIAL
- HEXALOBE VA SCREW
- LOCKING DRILL GUIDE
- LOCKING HEXALOBE SCREW
- NON-LOCKING HEXALOBE SCREW
- POINTED FORCEPS W/RATCHET
- QR DRILL LAG
- QR DRILL W/DEPTH MARKS
- REDUCTION FORCEPS W/RATCHET
- THREADED VA DRILL GUIDE
- THREADED VA DRILL GUIDE DRIVER
- TORQUE LIMITING QUICK CONNECT
- VA DRILL GUIDE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.