510(k) K952943

CONSENSUS ALL POLY TIBIA by U.S. Medical Products, Inc. — Product Code JWH

K952943 is an FDA 510(k) premarket notification submitted by U.S. Medical Products, Inc. for the device "CONSENSUS ALL POLY TIBIA". The FDA issued a decision of Substantially Equivalent on April 1, 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.