510(k) K033109

ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS by Scient'X — Product Code MQP

K033109 is an FDA 510(k) premarket notification submitted by Scient'X for the device "ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS". The FDA issued a decision of Substantially Equivalent on March 23, 2004. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Scient'X has at least 10 other 510(k) clearances on record.