510(k) K031635

DEPUY ACROMED VBR SYSTEM by Depuyacromed — Product Code MQP

K031635 is an FDA 510(k) premarket notification submitted by Depuyacromed for the device "DEPUY ACROMED VBR SYSTEM". The FDA issued a decision of Substantially Equivalent on June 23, 2003. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Depuyacromed has at least 10 other 510(k) clearances on record.