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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 EAST BELL DRIVE
WARSAW,  IN  46581 -0587
Applicant Contact GARY BAKER, M.S. RAC
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
WARSAW,  IN  46581 -0587
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
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