510(k) K060513

SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X by Sintea Biotech, Inc. — Product Code KWP

K060513 is an FDA 510(k) premarket notification submitted by Sintea Biotech, Inc. for the device "SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X". The FDA issued a decision of Substantially Equivalent on March 10, 2006. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Sintea Biotech, Inc. has at least 9 other 510(k) clearances on record.