510(k) K111184

APEX PS KNEE SYSTEM - PS-C INSERT by Omni Life Science, Inc. — Product Code JWH

K111184 is an FDA 510(k) premarket notification submitted by Omni Life Science, Inc. for the device "APEX PS KNEE SYSTEM - PS-C INSERT". The FDA issued a decision of Substantially Equivalent on June 22, 2011. 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.