510(k) K140452

VEGA KNEE SYSTEM by Aesculap Implant Systems — Product Code JWH

K140452 is an FDA 510(k) premarket notification submitted by Aesculap Implant Systems for the device "VEGA KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 25, 2014. 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 Implant Systems has at least 10 other 510(k) clearances on record.