510(k) K142942

HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System by Arthrosurface, Inc. — Product Code HSD

K142942 is an FDA 510(k) premarket notification submitted by Arthrosurface, Inc. for the device "HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System". The FDA issued a decision of Substantially Equivalent on December 19, 2014. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Arthrosurface, Inc. has at least 10 other 510(k) clearances on record.