510(k) K143443

VEGA Knee System, Columbus Total Knee System by Aesculap Implants Systems, LLC — Product Code JWH

K143443 is an FDA 510(k) premarket notification submitted by Aesculap Implants Systems, LLC for the device "VEGA Knee System, Columbus Total Knee System". The FDA issued a decision of Substantially Equivalent on March 25, 2015. 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. Aesculap Implants Systems, LLC has at least 3 other 510(k) clearances on record.