Clearance Summary
Dione PEEK Screw System received FDA 510(k) clearance under submission number K253130, sponsored by ZheJiang Decans Medical Devices 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 2026-05-27.
- Submission: K253130
- Applicant / Sponsor: ZheJiang Decans Medical Devices Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2026-05-27
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.