510(k) K081145

MODIFICATION TO 4CIS VANE SPINE SYSTEM by Solco Biomedical Co., Ltd. — Product Code MNI

K081145 is an FDA 510(k) premarket notification submitted by Solco Biomedical Co., Ltd. for the device "MODIFICATION TO 4CIS VANE SPINE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 5, 2008. The device falls under product code MNI (Orthosis, Spinal Pedicle 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.