Medical device licence · 97564 · Class 3
PROSTEP MICA SCREW SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 22, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97564
- Licence holder
- Wright Medical Technology, IncArlington, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 22, 2016
- Devices covered
- 28
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELEVATOR
- MICA CANNULATED COUNTERSINK
- MICA CANNULATED DRILL BIT
- MICA CURVED ELEVATOR
- MICA DEPTH GAUGE
- MICA DOUBLE ENDED RASP
- MICA DRILL BIT
- MICA DRILL BIT, CANNULATED
- MICA ELEVATOR, STRAIGHT
- MICA HEX DRIVER
- MICA SCREW
- PROSTEP MICA ANTI SKIVE PIN
- PROSTEP MICA DEPTH GAUGE
- PROSTEP MICA DRILL AND SCREW SLEEVE
- PROSTEP MICA DRILL BIT, SOLID
- PROSTEP MICA DRILL SLEEVE
- PROSTEP MICA FIRST MET
- PROSTEP MICA MEDIAL RECONTOURING GUIDE
- PROSTEP MICA SINGLE CHAMFER WIRE SLEEVE
- PROSTEP MICA SOLO ANCHORING PIN
- PROSTEP MICA SOLO ANTI SKIVE PIN
- PROSTEP MICA TARGET GUIDE PACK
- PROSTEP MICA TARGETING GUIDE BLOCK PROXIMAL
- PROSTEP MICA TARGETING GUIDE BODY
- PROSTEP MICA TARGETING GUIDE INSERT CENTRAL TRAJECTORY
- PROSTEP MICA TARGETING GUIDE INSERT LATERAL TRAJECTORY
- PROSTEP MICA TARGETING GUIDE INSERT MEDIAL TRAJECTORY
- PROSTEP MICA TARGETING GUIDE PIN
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.