510(k) K091406

ATLAS SPINE SPACER by Atlas Spine, LLC — Product Code MQP

K091406 is an FDA 510(k) premarket notification submitted by Atlas Spine, LLC for the device "ATLAS SPINE SPACER". The FDA issued a decision of Substantially Equivalent on September 4, 2009. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Atlas Spine, LLC has at least 10 other 510(k) clearances on record.