Clearance Summary
Fule Spinal Fixation System received FDA 510(k) clearance under submission number K252730, sponsored by Beijing Fule Science & Technology Development Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-10-24.
- Submission: K252730
- Applicant / Sponsor: Beijing Fule Science & Technology Development Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2025-10-24
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.