510(k) K112900

SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS by Lima Corporate S.P.A. — Product Code HSD

K112900 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS". The FDA issued a decision of Substantially Equivalent on June 1, 2012. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Lima Corporate S.P.A. has at least 10 other 510(k) clearances on record.