510(k) K162903

Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies by Exactech, Inc. — Product Code KWT

K162903 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies". The FDA issued a decision of Substantially Equivalent on February 27, 2017. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Exactech, Inc. has at least 10 other 510(k) clearances on record.