Medical device licence · 90625 · Class 3
COMPREHENSIVE SEGMENTAL REVISION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 6, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 90625
- Licence holder
- Biomet Orthopedics, Ata Biomet Sports Medicine, Ata Biomet Biologics, Ata Biomet TraumaWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 6, 2013
- Devices covered
- 25
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - ANTI-ROTATION INTERCALARY SEGMENT WITH SCREW
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - EAS HUMERAL HEAD
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - FLANGE LOCKING SCREW
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - FLANGE WITH SCREWS
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - HUMERAL COUPLER
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - INTERCALARY SEGMENT WITH SCREW
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - MODULAR PPS AUGMENT WITH SCREW
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - MODULAR REGENEREX AUGMENT
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - MODULAR STEM WITH SCREW
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - PROXIMAL BODY WITH SCREW
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - SOFT TISSUE AUGMENT SCREW
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - STEM WITH SCREW
- COMPREHENSIVE SEGMENTAL REVISION SYSTEM - TUMOR BODY
- COMPREHENSIVE SRS / NEXEL DISTAL BODY CEMENTED
- COMPREHENSIVE SRS / NEXEL DISTAL BODY TRIAL
- COMPREHENSIVE SRS INSTRUMENT ANTI-ROTATION SEGMENT TRIAL
- COMPREHENSIVE SRS INSTRUMENT BROACH/STEM TRIAL
- COMPREHENSIVE SRS INSTRUMENT BROACH/STEM TRIAL
- COMPREHENSIVE SRS INSTRUMENT DISTAL BODY TRIAL
- COMPREHENSIVE SRS INSTRUMENT FLANGE TRIAL
- COMPREHENSIVE SRS INSTRUMENT INTERCALARY SEGMENT TRIAL
- COMPREHENSIVE SRS INSTRUMENT PROXIMAL BODY TRIAL
- COMPREHENSIVE SRS INSTRUMENT PROXIMAL BODY TRIAL TUMOR
- COMPREHENSIVE SRS INSTRUMENT TOTAL HUMERAL COUPLER TRIAL
- COMPREHENSIVE SRS SEAS HEAD TRIAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.