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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K143697
Device Name Biomet Proximal Humerus Plating System
Applicant
Biomet Manufacturing
56 East Bell Drive, PO Box 587
Warsaw,  IN  46582
Applicant Contact Julie Largent
Correspondent
Biomet Manufacturing
56 East Bell Drive, PO Box 587
Warsaw,  IN  46582
Correspondent Contact Julie Largent
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/24/2014
Decision Date 03/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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