Medical device licence · 104560 · Class 3
COMPREHENSIVE REVERSE SHOULDER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 23, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104560
- Licence holder
- Zimmer Inc.Winterthur, SZ, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 23, 2020
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COMPREHENSIVE REVERSE SHOULDER SYSTEM MINI HUMERAL TRAY CO-CR-MO ALLOY
- COMPREHENSIVE REVERSE SHOULDER SYSTEM MINI HUMERAL TRAY TI-6AL-4V ALLOY
- COMPREHENSIVE REVERSE SHOULDER SYSTEM MINI HUMERAL TRAY TRIAL
- COMPREHENSIVE REVERSE SHOULDER SYSTEM, BEARING TRIAL
- COMPREHENSIVE REVERSE SHOULDER SYSTEM, PROLONG HIGHLY CROSSLINKED POLYETHYLENE BEARING
- COMPREHENSIVE REVERSE SHOULDER SYSTEM, VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE BEARING
- COMPREHENSIVE VERSA-DIAL REVERSE SHOULDER SYSTEM GLENOSPHERE
- COMPREHENSIVE VERSA-DIAL REVERSE SHOULDER SYSTEM GLENOSPHERE TRIAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.