Medical device licence · 104629 · Class 3
PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 13, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104629
- Licence holder
- Paragon 28, Inc.Englewood, CO, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 13, 2020
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANTI-ROTATION PEG
- CLAW GUIDE
- LOCKING SCREW
- NAIL
- NAIL, 3-HOLE
- OUTRIGGER ASSEMBLY
- OUTRIGGER SLIDER
- THREADED PEG
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.