510(k) K061016

EBI ESL PEEK-OPTIMA SPINE SYSTEM by Ebi, L.P. — Product Code MQP

K061016 is an FDA 510(k) premarket notification submitted by Ebi, L.P. for the device "EBI ESL PEEK-OPTIMA SPINE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 8, 2006. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Ebi, L.P. has at least 10 other 510(k) clearances on record.