510(k) K031837

MODIFICATION TO FORTITUDE CEMENT RESTRICTOR by Spinal Concepts, Inc. — Product Code JDK

K031837 is an FDA 510(k) premarket notification submitted by Spinal Concepts, Inc. for the device "MODIFICATION TO FORTITUDE CEMENT RESTRICTOR". The FDA issued a decision of Substantially Equivalent on July 24, 2003. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Spinal Concepts, Inc. has at least 10 other 510(k) clearances on record.