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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K071395
Device Name BIOMET VISION FOOTRING SYSTEM
Applicant
Biomet Manufacturing Corp
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact ROBERT FRIDDLE
Correspondent
Biomet Manufacturing Corp
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact ROBERT FRIDDLE
Regulation Number888.3030
Classification Product Code
KTT  
Date Received05/21/2007
Decision Date 07/09/2007
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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