510(k) K844488

MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS by Mecron Medical Products, Inc. — Product Code KWL

K844488 is an FDA 510(k) premarket notification submitted by Mecron Medical Products, Inc. for the device "MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS". The FDA issued a decision of Substantially Equivalent on March 12, 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.