Medical device licence · 103833 · Class 3
TORNIER HRS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 8, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103833
- Licence holder
- Tornier S.A.S.Montbonnot-Saint-Martin, France
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 8, 2019
- Devices covered
- 25
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CENTERED HUMERAL HEAD COUPLER TRIAL
- DRILL BIT
- HIGH OFFSET HUMERAL HEAD COUPLER TRIAL
- INLAY REAMER
- LOW OFFSET HUMERAL HEAD COUPLER TRIAL
- MONOBLOCK SOUNDER
- MONOBLOCK TRIAL STEM
- REVERSED TRAY TRIAL
- TORNIER HRS ASSEMBLY SCREW
- TORNIER HRS HUMERAL HEAD COUPLER
- TORNIER HRS LOCKING CAP
- TORNIER HRS MONOBLOCK STEM
- TORNIER HRS PTC DISTAL STEM
- TORNIER HRS PTC PARTIALLY COATED DISTAL
- TORNIER HRS PTC PARTIALLY COATED DISTAL STEM
- TORNIER HRS PTC PROXIMAL BODY
- TORNIER HRS REVERSED TRAY
- TORNIER HRS SOUNDER
- TORNIER HRS SPACER
- TORNIER HRS TRIAL TUBEROSITY BODY
- TORNIER HRS TUBEROSITY BODY
- TRIAL DISTAL STEM
- TRIAL PROXIMAL BODY
- TRIAL SPACER
- TRIAL STEM EXTENSION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.