Medical device licence · 97840 · Class 3
PEDIPLATES SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 27, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97840
- Licence holder
- Orthopediatrics CorporationWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 27, 2016
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AO CANNULATED DRILL
- CANNULATED DRILL, DELTA
- CANNULATED HEX SCREWDRIVER, AO FITTING
- CANNULATED SCREW
- CANNULATED SCREW, DELTA
- DIRECT MEASURING DEVICE
- DOUBLE DRILL GUIDE
- DOUBLE DRILL GUIDE, DELTA
- GUIDE WIRE
- HEX SCREW DRIVER, AO FITTING
- I-PLATE CENTER HOLE
- LP CANNULATED SCREW
- O-PLATE CENTER HOLE
- PEDIPLATE DELTA
- SELF-CENTERING DRILL GUIDE
- SELF-HOLDING SCREW FORCEPS
- SOLID SCREW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.