Medical device licence · 115441 · Class 3
R3ACT STABILIZATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 21, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115441
- Licence holder
- Paragon 28, Inc.Englewood, CO, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 21, 2026
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BREAKAWAY TREPHINE
- DRILL POINT K-WIRE
- GORILLA WASHER
- K-WIRE
- LATERAL REMOVAL DRIVER
- R3ACT IMPLANT, 14MM NOTCH
- R3ACT IMPLANT, 17MM NOTCH
- SOLID DRILL
- SOLID DRILL WITH PILOT NOSE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.