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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K072161
Device Name BIOMET FEMORAL LOCKING NAIL SYSTEM
Applicant
Biomet Manufacturing Corp
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact BECKY EARL
Correspondent
Biomet Manufacturing Corp
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact BECKY EARL
Regulation Number888.3020
Classification Product Code
HSB  
Date Received08/06/2007
Decision Date 09/20/2007
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
Recalls CDRH Recalls
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