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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 K192084
Device Name Madison Total Knee System
Applicant
Implanet, S.A.
Technopole Bordeaux Montesquieu, Allee Francois Magendie
Martillac,  FR 33650
Applicant Contact Regis Le Couedic
Correspondent
MCRA, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Hollace Saas Rhodes
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/02/2019
Decision Date 10/22/2019
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
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