510(k) K112470

2GC HIP/KNEE MODULAR SPACER by Mandell Horwitz Consultants, LLC — Product Code KWL

K112470 is an FDA 510(k) premarket notification submitted by Mandell Horwitz Consultants, LLC for the device "2GC HIP/KNEE MODULAR SPACER". The FDA issued a decision of Substantially Equivalent on April 5, 2012. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360.