Medical device licence · 97821 · Class 3
REUNION TSA SHOULDER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 13, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97821
- Licence holder
- Stryker GmbhSelzach, SO, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 13, 2016
- Devices covered
- 35
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALCAR PLANER
- CENTERING DRILL
- CENTERING DRILL GUIDE
- ECCENTRIC SR HUMERAL HEAD TRIAL
- FLUTED CYLINDRICAL REAMER
- HUMERAL BROACH
- KEELED DRILL GUIDE
- KEELED GLENOID SURFACE TRIAL
- KEELED GLENOID TRIAL
- PEG/KEEL DRILL
- PEGGED DRILL GUIDE
- PEGGED GLENOID SURFACE TRIAL
- PEGGED GLENOID TRIAL
- REUNION LOW-PROFILE CANNULATED REAMER DRIVER
- REUNION S CEMENTED HUMERAL STEM
- REUNION S HUMERAL BROACH
- REUNION S PRESS-FIT HUMERAL STEM
- REUNION TSA - CEMENTED HUMERAL STEM
- REUNION TSA - CEMENTED LONG HUMERAL STEM
- REUNION TSA - PRESS-FIT HUMERAL STEM
- REUNION TSA - SR OFFSET HUMERAL HEAD
- REUNION TSA - SR STANDARD HUMERAL HEAD
- REUNION TSA ANGLED REAMER DRIVER
- REUNION TSA CANNULATED CENTERING GUIDE
- REUNION TSA CANNULATED GLENOID REAMER
- REUNION TSA CANNULATED HALF-MOON REAMER
- REUNION TSA CLAMP TOWER
- REUNION TSA EXTRAMEDULLARY RESECTION GUIDE ASSEMBLY
- REUNION TSA INTRAMEDULLARY RESECTION GUIDE ASSEMBLY
- REUNION TSA MODULAR DRILL BIT-STANDARD
- REUNION TSA SELF-PRESSURING GLENOID X3 KEELED GLENOID
- REUNION TSA SELF-PRESSURING GLENOID X3 PEGGED GLENOID
- REUNION TSA STANDARD RESECTION GUIDE BLOCK
- SPHERICAL GLENOID REAMER
- STRAIGHT REAMER DRIVER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.