510(k) K063464

ATLAS SPINE VERTEBRAL BODY REPLACEMENT by Atlas Spine, Inc. — Product Code MQP

K063464 is an FDA 510(k) premarket notification submitted by Atlas Spine, Inc. for the device "ATLAS SPINE VERTEBRAL BODY REPLACEMENT". The FDA issued a decision of Substantially Equivalent on March 9, 2007. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Atlas Spine, Inc. has at least 10 other 510(k) clearances on record.