510(k) K041989

SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X by Sintea Biotech, Inc. — Product Code KWQ

K041989 is an FDA 510(k) premarket notification submitted by Sintea Biotech, Inc. for the device "SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X". The FDA issued a decision of Substantially Equivalent on September 16, 2004. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Sintea Biotech, Inc. has at least 9 other 510(k) clearances on record.