510(k) K051525

ARX SPINAL SYSTEM by Amedica Corp. — Product Code MQP

K051525 is an FDA 510(k) premarket notification submitted by Amedica Corp. for the device "ARX SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on February 17, 2006. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Amedica Corp. has at least 10 other 510(k) clearances on record.