510(k) K131298

EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM by Exactech, Inc. — Product Code HSD

K131298 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM". The FDA issued a decision of Substantially Equivalent on November 26, 2013. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Exactech, Inc. has at least 10 other 510(k) clearances on record.