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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 K173826
Device Name THP Hip Fracture Plating System
Applicant
Biomet, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Applicant Contact Annette Minthorn
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Correspondent Contact Annette Minthorn
Regulation Number888.3030
Classification Product Code
JDO  
Subsequent Product Codes
HWC   KTT  
Date Received12/18/2017
Decision Date 02/07/2018
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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