Clearance Summary
Rexious Spinal Fixation System received FDA 510(k) clearance under submission number K173131, sponsored by Huvexel Co. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-12-08.
- Submission: K173131
- Applicant / Sponsor: Huvexel Co. , Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2017-12-08
Classification & Regulation
This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.