510(k) K023096

CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM by Std Mfg., Inc. — Product Code HSD

K023096 is an FDA 510(k) premarket notification submitted by Std Mfg., Inc. for the device "CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 10, 2003. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Std Mfg., Inc. has at least 5 other 510(k) clearances on record.