Clearance Summary
Ideal pedicle screw spinal system received FDA 510(k) clearance under submission number K142957, sponsored by Jiangsu Ideal Medical Science & Technology 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 2015-01-30.
- Submission: K142957
- Applicant / Sponsor: Jiangsu Ideal Medical Science & Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2015-01-30
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.