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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K143106
Device Name VEGA Knee System
Applicant
Aesculap Implant Systems, LLC
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact Julie Tom Wing
Correspondent
Aesculap Implant Systems, LLC
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Julie Tom Wing
Regulation Number888.3560
Classification Product Code
JWH  
Date Received10/29/2014
Decision Date 11/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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