Medical device licence · 82586 · Class 3
POLARCUP DUAL MOBILITY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 16, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82586
- Licence holder
- Smith & Nephew Orthopaedics AgWarwickshire, United Kingdom
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 16, 2010
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FLEXIBLE TWIST DRILL
- POLARCUP - SHELL TI/HA (WITH PEGS AND FLANGES)
- POLARCUP ANCHORING PEG
- POLARCUP CORTICAL SCREW
- POLARCUP PE INSERT
- POLARCUP PE X-LINKED INSERT
- POLARCUP SHELL CEMENTED
- POLARCUP SHELL TI-PLASMA
- POLARCUP TRIAL INSERT
- POLARCUP TRIAL INSERT NAV
- POLARCUP TRIAL SHELL
- TWIST DRILL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.