Medical device licence · 110905 · Class 3
PROSTEP MIS 5MM CHAMFER SCREW SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 4, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 110905
- Licence holder
- Wright Medical Technology, IncArlington, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 4, 2024
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROSTEP MIS ARTHRODESIS CORTICAL BURR, SHAPE: WEDGE
- PROSTEP MIS ARTHRODESIS FENESTRATION AWL
- PROSTEP MIS ARTHRODESIS IRRIGATION SLEEVE
- PROSTEP MIS CHAMFER SCREW
- PROSTEP MIS COMPRESSION PACK
- PROSTEP MIS DRILL & DEPTHING PACK
- PROSTEP MIS LAPIDUS DISTRACTOR-COMPRESSOR PLACEMENT GUIDE
- PROSTEP MIS LAPIDUS DISTRACTOR-COMPRESSOR WIRE SLEEVE
- PROSTEP MIS LAPIDUS K-WIRE PACK
- PROSTEP MIS LAPIDUS KEYSTONE TARGETING GUIDE LEFT
- PROSTEP MIS LAPIDUS KEYSTONE TARGETING GUIDE RIGHT
- PROSTEP MIS LAPIDUS SCREW TARGETING GUIDE LEFT
- PROSTEP MIS LAPIDUS SCREW TARGETING GUIDE RIGHT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.