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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 K151603
Device Name Arcos One-piece Femoral Revision System
Applicant
Biomet, Inc.
56 East Bell Drive.P.O.Box 587
Warsaw,  IN  46581
Applicant Contact Tracy Johnson
Correspondent
BIOMET UK LTD.
WATERTON INDUSTRIAL ESTATE
BRIDGEND,  GB CF31 3XA
Correspondent Contact PAUL CUTLAN
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LWJ  
LZO   OQG   OQH   OQI   PBI  
Date Received06/12/2015
Decision Date 10/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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