Clearance Summary
Metallic Locking Bone Plate and Screw received FDA 510(k) clearance under submission number K142943, sponsored by Canwell Medical 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 2015-08-03.
- Submission: K142943
- Applicant / Sponsor: Canwell Medical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2015-08-03
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.