510(k) K150501

Zimmer Nexel Total Elbow Ulnar Cement Diverter by Zimmer, Inc. — Product Code JDC

K150501 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Zimmer Nexel Total Elbow Ulnar Cement Diverter". The FDA issued a decision of Substantially Equivalent on April 23, 2015. The device falls under product code JDC (Prosthesis, Elbow, Constrained, Cemented), a Class II device regulated under 21 CFR 888.3150. Zimmer, Inc. has at least 10 other 510(k) clearances on record.