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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, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K131167
Device Name UNIVATION
Applicant
AESCULAP IMPLANT SYSTEMS, LLC
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact JULIE T WING
Correspondent
AESCULAP IMPLANT SYSTEMS, LLC
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact JULIE T WING
Regulation Number888.3530
Classification Product Code
HRY  
Date Received04/24/2013
Decision Date 10/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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