510(k) K081631

SINTEA BIOTECH PLS MULTI-AXIAL SCREWS by Sintea Biotech, Inc. — Product Code MNH

K081631 is an FDA 510(k) premarket notification submitted by Sintea Biotech, Inc. for the device "SINTEA BIOTECH PLS MULTI-AXIAL SCREWS". The FDA issued a decision of Substantially Equivalent on July 18, 2008. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Sintea Biotech, Inc. has at least 9 other 510(k) clearances on record.