VEGA Knee System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

AESCULAP IMPLANT SYSTEMS, LLC

The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Vega Knee System.

Pre-market Notification Details

Device IDK143106
510k NumberK143106
Device Name:VEGA Knee System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant AESCULAP IMPLANT SYSTEMS, LLC 3773 CORPORATE PARKWAY Center Valley,  PA  18034
ContactJulie Tom Wing
CorrespondentJulie Tom Wing
AESCULAP IMPLANT SYSTEMS, LLC 3773 CORPORATE PARKWAY Center Valley,  PA  18034
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-29
Decision Date2014-11-21
Summary:summary

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