Medical device licence · 103024 · Class 3
TRIDENT II ACETABULAR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 3, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103024
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 3, 2019
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BALL JOINT DRILL SHAFT
- DEPTH GAUGE
- DRILL BIT
- DRILL GUIDE
- HEX DOME HOLE PLUG
- LOW PROFILE HEX SCREW
- SINGLE USE DRILL BIT
- TRIAL INSERT HEX CONTAINMENT SCREW KIT
- TRIDENT II CLUSTERHOLE HA ACETABULAR SHELL
- TRIDENT II PSL CLUSTERHOLE HA ACETABULAR SHELL
- TRIDENT II TRITANIUM CLUSTERHOLE ACETABULAR SHELL
- TRIDENT II TRITANIUM MULTIHOLE ACETABULAR SHELL
- TRIDENT II TRITANIUM SOLIDBACK ACETABULAR SHELL
- WINDOW TRIAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.