Medical device licence · 113877 · Class 3
PHANTOM FIBULA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 27, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113877
- Licence holder
- Paragon 28, Inc.Englewood, CO, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 27, 2025
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CURVED REAMER GUIDE
- DISTAL REAMER, CANNULATED, AO QUICK CONNECT
- DRILL BIT, CALIBRATED, AO QUICK CONNECT
- EASY-OUT REMOVAL TOOL, AO QUICK CONNECT
- END CAP, TI
- ENTRY GUIDEWIRE, TROCAR
- HALF OLIVE WIRE, THREADED
- PHANTOM FIBULA NAIL
- PROXIMAL REAMER, CANNULATED, AO QUICK CONNECT
- PROXIMAL REAMER, SOLID, AO QUICK CONNECT
- R3ACT DRILL BIT, CALIBRATED, AO QUICK CONNECT
- R3FLEX STEP DRILL BIT, CALIBRATED, AO QUICK CONNECT
- SCREW COUNTERSINK, AO QUICK CONNECT
- SINGLE LEAD TAP, AO QUICK CONNECT
- THREADED PEG, TI
- TROCAR K-WIRE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.