Medical device licence · 104252 · Class 3
CANNULATED SCREW SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 6, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104252
- Licence holder
- Orthopediatrics CorporationWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 6, 2020
- Devices covered
- 25
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AO CANNULATED TAP
- CANNULATED COUNTERSINK
- CANNULATED DRILL
- CANNULATED SCREW WASHER
- CANNULATED SCREW, FULLY THREADED, (LARGE)
- CANNULATED SCREW, FULLY THREADED, (SMALL)
- CANNULATED SCREW, MEDIUM THREAD, (LARGE)
- CANNULATED SCREW, MEDIUM THREAD, (SMALL)
- CANNULATED SCREW, SHORT THREAD, (LARGE)
- CANNULATED SCREW, SHORT THREAD, (SMALL)
- DIRECT MEASURING DEVICE
- DOUBLE DRILL GUIDE
- DRILL PERCUTANEOUS SLEEVE INSERT
- EASY OUT (CHRISTMAS TREE)
- GUIDE WIRE, THREADED
- HEX EASY OUT
- PARALLEL WIRE GUIDE, ADJUSTABLE
- SCREW HEAD RETAINING SLEEVE
- SCREW INSTRUMENTATION
- SCREW PERCUTANEOUS SLEEVE W/ HANDLE
- SECONDARY WIRE POSITIONER
- SMOOTH GUIDE WIRE
- TREPHINE
- TROCAR PERCUTANEOUS SLEEVE INSERT
- WIRE PERCUTANEOUS SLEEVE INSERT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.