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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Proximal Femoral, Implant
510(k) Number K140018
Device Name TSP HIP FRACTURE PLATING SYSTEM
Applicant
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581
Applicant Contact GARY BAKER
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581
Correspondent Contact GARY BAKER
Regulation Number888.3030
Classification Product Code
JDO  
Subsequent Product Code
KTT  
Date Received01/03/2014
Decision Date 04/04/2014
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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