510(k) K060696

ACCLAIM TOTAL ELBOW SYSTEM by DePuy Orthopaedics, Inc. — Product Code JDC

K060696 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "ACCLAIM TOTAL ELBOW SYSTEM". The FDA issued a decision of Substantially Equivalent on April 14, 2006. The device falls under product code JDC (Prosthesis, Elbow, Constrained, Cemented), a Class II device regulated under 21 CFR 888.3150. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.