Medical device licence · 111486 · Class 3
GRAPPLER INTERFERENCE SCREW SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 9, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111486
- Licence holder
- Paragon 28, Inc.Englewood, CO, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 9, 2024
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BLIND-TUNNEL DRIVER HANDLE W/AO CONNECT W/SUTURE CLEAT
- INTERFERENCE SCREW
- SCREW DRIVER ATTACHMENT, CANNULATED, A/O, TRILOBE, GRAPPLER
- SCREW DRIVER ATTACHMENT, DRIVER SLEEVE
- SCREW DRIVER ATTACHMENT, SOLID, A/O, TRILOBE, GRAPPLER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.