510(k) K090764

NOVATION CFS PRESS-FIT AND CEMENTED STEMS by Exactech, Inc. — Product Code LWJ

K090764 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "NOVATION CFS PRESS-FIT AND CEMENTED STEMS". The FDA issued a decision of Substantially Equivalent on April 21, 2009. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Exactech, Inc. has at least 10 other 510(k) clearances on record.