Medical device licence · 103338 · Class 3
PEDILOC FRAGMENT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 26, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103338
- Licence holder
- Orthopediatrics CorporationWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 26, 2019
- Devices covered
- 43
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 1/3 TUBULAR PLATE
- 1/4 TUBULAR PLATE
- AO CANNULATED DRILL
- AO CANNULATED TAP
- BENDING TEMPLATE
- BONE REDUCTION FORCEPS POINTED TIPS
- BONE SCOOP
- BONE SCREW WASHER
- CALIBRATED DRILL BIT
- CANNULATED CANCELLOUS SCREW, FULL THREAD
- CANNULATED CANCELLOUS SCREW, PARTIAL THREAD
- CANNULATED COUNTERSINK
- CANNULATED DRIVER
- CORTICAL SCREW, T10
- CORTICAL TAP
- DEPTH GAUGE
- DIRECT MEASURING DEVICE
- DOUBLE DRILL GUIDE
- DOUBLE DRILL SLEEVE
- DRILL BIT
- DRILL GUIDE/SLEEVE PARALLEL
- GUIDE WIRE
- GUIDE WIRE, COCR
- GUIDE WIRE, THREADED
- HOLDING CLIP
- LOCKING COMPRESSION PLATE
- LOCKING SCREW, T10
- LOCKING T-PLATE
- MINI INLINE- RATCHET WITH SMALL AO PUSH/PULL COUPLING
- NEUTRAL & LOAD DRILL GUIDE
- NEUTRAL & LOAD END DRILL GUIDE
- ORTHOPEDIATRIC BENDING IRON
- PLATE FIXATION PIN
- RECONSTRUCTION PLATE
- RETAINING DRIVER
- SCALE
- SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE
- SELF-HOLDING SCREW FORCEPS
- SHARP HOOK
- THREADED DRILL GUIDE
- TOOTHED BONE REDUCTION FORCEPS
- TOP HAT
- WIRE, SMOOTH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.