Clearance Summary
IDEAL received FDA 510(k) clearance under submission number K132428, sponsored by Jiangsu Ideal Medical Science & Technology Co., LT. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-12-20.
- Submission: K132428
- Applicant / Sponsor: Jiangsu Ideal Medical Science & Technology Co., LT
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2013-12-20
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.