510(k) K071676

EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS by Exactech, Inc. — Product Code KWZ

K071676 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS". The FDA issued a decision of Substantially Equivalent on July 19, 2007. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. Exactech, Inc. has at least 10 other 510(k) clearances on record.