510(k) K043578

THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM by Solco Biomedical Co., Ltd. — Product Code MNH

K043578 is an FDA 510(k) premarket notification submitted by Solco Biomedical Co., Ltd. for the device "THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM". The FDA issued a decision of Substantially Equivalent on March 7, 2005. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Solco Biomedical Co., Ltd. has at least 10 other 510(k) clearances on record.