510(k) K063791

CORIN UNIPOLAR MODULAR HEAD by Corin USA — Product Code KWL

K063791 is an FDA 510(k) premarket notification submitted by Corin USA for the device "CORIN UNIPOLAR MODULAR HEAD". The FDA issued a decision of Substantially Equivalent on April 3, 2007. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Corin USA has at least 10 other 510(k) clearances on record.