510(k) K061098

EBI OPTILOCK PERIARTICULAR PLATING SYSTEM by Ebi, L.P. — Product Code HRS

K061098 is an FDA 510(k) premarket notification submitted by Ebi, L.P. for the device "EBI OPTILOCK PERIARTICULAR PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 24, 2006. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Ebi, L.P. has at least 10 other 510(k) clearances on record.