510(k) K844487

MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR by Mecron Medical Products, Inc. — Product Code KWL

K844487 is an FDA 510(k) premarket notification submitted by Mecron Medical Products, Inc. for the device "MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR". The FDA issued a decision of Substantially Equivalent on February 19, 1985. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Mecron Medical Products, Inc. has at least 10 other 510(k) clearances on record.