Medical device licence · 103196 · Class 3
LOCKING CANNULATED BLADE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 15, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103196
- Licence holder
- Orthopediatrics CorporationWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 15, 2019
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 100 DEG LOCKING CANNULATED CHILD BLADE
- 100 DEGREE LOCKING CANNULATED ADOLESCENT BLADE
- 110 DEGREE CANNULATED ADOLESCENT BLADE PLATE
- 130 DEG LOCKING CANNULATED ADOLESCENT BLADE
- 130 DEG LOCKING CANNULATED CHILD BLADE
- 130 DEGREE LOCKING CANNULATED INFANT BLADE
- 3.5 MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE
- 3.5 MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE
- 4.5 MM LOCKING SCREW
- 4.5 MM SELF TAPPING CORTICAL SCREW
- 4.5 MM SELF TAPPING CORTICAL SCREW WITH T20 HEXALOBE
- 90 DEG LOCKING CANNULATED ADOLESCENT BLADE
- 90 DEG LOCKING CANNULATED CHILD BLADE
- 90 DEG LOCKING CANNULATED INFANT BLADE
- CALIBRATED DRILL BIT
- DRILL BIT
- DRILL BIT CALIBRATED
- GUIDE WIRE
- RETAINING DRIVER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.