510(k) K082453

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

K082453 is an FDA 510(k) premarket notification submitted by Solco Biomedical Co., Ltd. for the device "4CIS SOLAR AND APOLLON SPINE SYSTEMS". The FDA issued a decision of Substantially Equivalent on September 23, 2008. 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.