510(k) K032812

ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT by Orthovita, Inc. — Product Code MQP

K032812 is an FDA 510(k) premarket notification submitted by Orthovita, Inc. for the device "ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT". The FDA issued a decision of Substantially Equivalent on December 8, 2003. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Orthovita, Inc. has at least 10 other 510(k) clearances on record.