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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, Single Component
510(k) Number K001271
Device Name SAMARCO SPIDER PLATES
Applicant
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581 -0587
Applicant Contact MARY VERSTYNEN
Correspondent
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581 -0587
Correspondent Contact MARY VERSTYNEN
Regulation Number888.3030
Classification Product Code
KTW  
Date Received04/20/2000
Decision Date 07/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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