510(k) K031154

SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X by Sintea Biotech, Inc. — Product Code JDW

K031154 is an FDA 510(k) premarket notification submitted by Sintea Biotech, Inc. for the device "SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X". The FDA issued a decision of Substantially Equivalent on June 24, 2003. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Sintea Biotech, Inc. has at least 9 other 510(k) clearances on record.