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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 K121149
Device Name VANGUARD SSK 360 REVISION KNEE SYSTEM
Applicant
Biomet Manufacturing Corp
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact GARY BAKER, M.S. RAC
Correspondent
Biomet Manufacturing Corp
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact GARY BAKER, M.S. RAC
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/16/2012
Decision Date 05/16/2012
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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