510(k) K953443

CONSENSUS PCL SUBSITUTING TIBIAL INSERT by U.S. Medical Products, Inc. — Product Code JWH

K953443 is an FDA 510(k) premarket notification submitted by U.S. Medical Products, Inc. for the device "CONSENSUS PCL SUBSITUTING TIBIAL INSERT". The FDA issued a decision of Substantially Equivalent on April 26, 1996. 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. U.S. Medical Products, Inc. has at least 10 other 510(k) clearances on record.