510(k) K061698

MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR by Life Spine — Product Code JDK

K061698 is an FDA 510(k) premarket notification submitted by Life Spine for the device "MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR". The FDA issued a decision of Substantially Equivalent on July 12, 2006. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Life Spine has at least 10 other 510(k) clearances on record.