Clearance Summary
Flow-Screw received FDA 510(k) clearance under submission number K142776, sponsored by Flow-Fx, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2015-03-23.
- Submission: K142776
- Applicant / Sponsor: Flow-Fx, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2015-03-23
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.