510(k) K102458

4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM by Solco Biomedical Co., Ltd. — Product Code MNH

K102458 is an FDA 510(k) premarket notification submitted by Solco Biomedical Co., Ltd. for the device "4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 13, 2011. 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.