510(k) K192148

Freedom Primary PCK by Maxx Orthopedics, Inc. — Product Code JWH

K192148 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Freedom Primary PCK". The FDA issued a decision of Substantially Equivalent on September 5, 2019. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Maxx Orthopedics, Inc. has at least 10 other 510(k) clearances on record.