510(k) K070181

SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX by Sintea Biotech, Inc. — Product Code MQP

K070181 is an FDA 510(k) premarket notification submitted by Sintea Biotech, Inc. for the device "SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX". The FDA issued a decision of Substantially Equivalent on April 18, 2007. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Sintea Biotech, Inc. has at least 9 other 510(k) clearances on record.