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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K130063
Device Name ARCOS TROCHANTER BUTTON
Applicant
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581
Applicant Contact BECKY EARL
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581
Correspondent Contact BECKY EARL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDG   JDI   KWY   KWZ   LWJ  
LZO   MAY   MEH   OQG   OQH   OQI  
PBI  
Date Received01/10/2013
Decision Date 04/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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