Medical device licence · 11846 · Class 3
BIO-MODULAR TOTAL SHOULDER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 14, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 11846
- 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
- September 14, 1999
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIO-MODULAR CHOICE INSTRUMENTS PROVISIONAL RASP
- BIO-MODULAR CHOICE INSTRUMENTS RASP COLLAR
- BIO-MODULAR CHOICE INSTRUMENTS RASP/PROVISIONAL
- BIO-MODULAR GLENOID PROVISIONAL INSERT
- BIO-MODULAR HUMERAL HEAD PROVISIONAL
- BIO-MODULAR HUMERAL RASP
- BIO-MODULAR PROVISIONAL HUMERAL HEAD EXTENDED ARTICULAR SURFACE
- BIO-MODULAR PROVISIONAL HUMERAL STEM WITH ALIGNMENT HOLE
- BIO-MODULAR PROVISIONAL OFFSET HEAD
- BIO-MODULAR SHOULDER OFFSET HEAD
- BIO-MODULAR SHOULDER PEGGED GLENOID PROVISIONAL
- BIO-MODULAR SHOULDER PROVISIONAL FOR POROUS COATED GLENOID
- BIO-MODULAR SHOULDER SYSTEM - GLENOID SHELL LOW PROFILE POROUS
- BIO-MODULAR SHOULDER SYSTEM - HUMERAL HEAD EXTENDED ARTICULAR SURFACE
- BIO-MODULAR SHOULDER SYSTEM - HUMERAL HEAD-NECK
- BIO-MODULAR SHOULDER SYSTEM - HUMERAL WITH ALIGNMENT HOLE, POROUS COATED
- BIO-MODULAR SHOULDER SYSTEM - OFFSET HEAD
- BIO-MODULAR/COMPREHENSIVE KEELED GLENOID PROVISIONAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.