510(k) K120313

NEO CR KNEE SYSTEM by Pipeline Orthopedics — Product Code JWH

K120313 is an FDA 510(k) premarket notification submitted by Pipeline Orthopedics for the device "NEO CR KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 20, 2012. 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. Pipeline Orthopedics has at least 8 other 510(k) clearances on record.