Medical device licence · 73082 · Class 3
GLADIATOR BIPOLAR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 11, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 73082
- Licence holder
- Microport Orthopedics Inc.Arlington, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 11, 2007
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GLADIATOR BIOPOLAR TRIAL HEAD
- GLADIATOR BIOPOLAR TRIAL HEAD - PERFECTA
- GLADIATOR BIOPOLAR TRIAL HEAD - PROFEMUR
- GLADIATOR BIOPOLAR TRIAL SHELL
- GLADIATOR BIPOLAR SHELL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.