510(k) K130634

CORIN METAFIX HIP STEM by Corin USA — Product Code LZO

K130634 is an FDA 510(k) premarket notification submitted by Corin USA for the device "CORIN METAFIX HIP STEM". The FDA issued a decision of Substantially Equivalent on May 24, 2013. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Corin USA has at least 10 other 510(k) clearances on record.