Clearance Summary
RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW received FDA 510(k) clearance under submission number K112819, sponsored by Xiamen Double Engline Medical Material 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 2011-12-16.
- Submission: K112819
- Applicant / Sponsor: Xiamen Double Engline Medical Material Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2011-12-16
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.