510(k) K082715

DEPUY GLOBAL AP CTA HUMERAL HEAD by DePuy Orthopaedics, Inc. — Product Code HSD

K082715 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "DEPUY GLOBAL AP CTA HUMERAL HEAD". The FDA issued a decision of Substantially Equivalent on December 18, 2008. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.