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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
Original Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
warsaw,  IN  46581 -0587
Original 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
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