Medical device licence · 11778 · Class 3
ATLAS SHOULDER SYSTEM
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed September 13, 1999; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 11778
- Licence holder
- Kirschner Medical CorporationWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 13, 1999
- Ended
- February 16, 2004
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ATLAS MODULAR DISTAL STETENSION
- ATLAS MODULAR PROXIMAL HUMERAL COMPONENT, NON COATED
- ATLAS-C MODULAR PROXIMAL HUMERAL COMPONENT PLASMA SPRAYED
- CORTICAL BONE SCREW
- GLENOID COMPONENTS
- MODULAR H-C HUMERAL STEM
- MODULAR HUMERAL HEAD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.