510(k) K150680

Freedom Cementless Femoral Component by Maxx Orthopedics, Inc. — Product Code MBH

K150680 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Freedom Cementless Femoral Component". The FDA issued a decision of Substantially Equivalent on June 26, 2015. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Maxx Orthopedics, Inc. has at least 10 other 510(k) clearances on record.