Clearance Summary
Flex-Thread Ulna Intramedullary Nail System received FDA 510(k) clearance under submission number K222390, sponsored by Flower Orthopedics Corporation Dba Conventus Flower. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-11-21.
- Submission: K222390
- Applicant / Sponsor: Flower Orthopedics Corporation Dba Conventus Flower
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2022-11-21
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.