510(k) K050348

CO VERTEBRAL BODY REPLACEMENT by Scient'X — Product Code MQP

K050348 is an FDA 510(k) premarket notification submitted by Scient'X for the device "CO VERTEBRAL BODY REPLACEMENT". The FDA issued a decision of Substantially Equivalent on May 27, 2005. 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.