510(k) K142388

Neo Total Knee System by New Era Orthopedics, LLC — Product Code JWH

K142388 is an FDA 510(k) premarket notification submitted by New Era Orthopedics, LLC for the device "Neo Total Knee System". The FDA issued a decision of Substantially Equivalent on Dec 5, 2014. 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. New Era Orthopedics, LLC has at least 1 other 510(k) clearance on record.