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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 K101281
Device Name VEGA KNEE SYSTEM
Applicant
Aesculap Implant System, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact KATHY A RACOSKY
Correspondent
Aesculap Implant System, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact KATHY A RACOSKY
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/06/2010
Decision Date 07/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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