510(k) K094017

TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 by Omni Life Science, Inc. — Product Code JWH

K094017 is an FDA 510(k) premarket notification submitted by Omni Life Science, Inc. for the device "TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158". The FDA issued a decision of Substantially Equivalent on March 5, 2010. 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. Omni Life Science, Inc. has at least 10 other 510(k) clearances on record.