Medical device licence · 71044 · Class 3
INGEN TOTAL SHOULDER REPLACEMENT SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed April 5, 2006; ended February 7, 2008. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 71044
- Licence holder
- Ingen Orthopedics, LlcCranbury, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 5, 2006
- Ended
- February 7, 2008
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INGEN TOTAL SHOULDER REPLACEMENT SYSTEM - HUMERAL HEAD OFFSET
- INGEN TOTAL SHOULDER REPLACEMENT SYSTEM - HUMERAL HEAD STANDARD
- INGEN TOTAL SHOULDER REPLACEMENT SYSTEM - HUMERAL STEM
- INGEN TOTAL SHOULDER REPLACEMENT SYSTEM - KEELED GLENOID
- INGEN TOTAL SHOULDER REPLACEMENT SYSTEM - PEGGED GLENOID
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.