Medical device licence · 104634 · Class 3
PEDIFOOT DEFORMITY CORRECTION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 9, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104634
- Licence holder
- Orthopediatrics CorporationWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 9, 2020
- Devices covered
- 37
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANGLE IRON
- ANGLE IRON CUT GUIDE
- BENDING IRON
- CLOVER PLATE
- COLLET WIRE GUIDE
- COMPRESSION PLATE
- CORTICAL SCREW
- CUT GUIDE
- CUT GUIDE, CHEVRON/SCARF
- CUT GUIDE, LATERAL CALCANEUS
- DEPTH GAUGE HOUSING
- DEPTH GAUGE SLIDING INSERT
- DOUBLE DRILL GUIDE
- DRILL, CALIBRATED
- FIXED ANGLE DRILL GUIDE
- FOOT PUSHER HANDLE
- FOOT PUSHER KNOB
- FOOT PUSHER PLATFORM
- GEDNEY-GIBBS DISTRACTOR
- GUIDE WIRE PARTIALLY THREADED SHAFT
- HEEL HANDLER
- IN-LINE CUT GUIDE
- K WIRE SMOOTH
- K WIRE THREADED TIP
- LATERAL COLUMN LENGTHENING MEASUREMENT TOOL
- MINI TACK THREADED
- MINI TACK, SMOOTH
- MINI TAP N JACK
- OLIVE WIRE
- RECON PLATE
- SMALL PLATE COMPRESSION DEVICE
- SOLID DRIVER, NON-RETAINING
- SOLID DRIVER, RETAINING
- TENDON PASSER
- VARIABLE ANGLE DRILL GUIDE
- VARIABLE ANGLE LOCKING SCREW
- WEDGE PLATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.