Medical device licence · 12458 · Class 3
GLOBAL TOTAL SHOULDER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 23, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 12458
- Licence holder
- Depuy Orthopaedics, Inc.Warsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 23, 1999
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GLOBAL TOTAL SHOULDER SYSTEM - FINNED GLENOID W/ HYLAMER
- GLOBAL TOTAL SHOULDER SYSTEM - HUMERAL BODY COMPONENT (CEMENTED/UNCEMENTED)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.