Clearance Summary
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM received FDA 510(k) clearance under submission number K043578, sponsored by Solco Biomedical 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 2005-03-07.
- Submission: K043578
- Applicant / Sponsor: Solco Biomedical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2005-03-07
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.