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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 K052255
Device Name ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS
Applicant
Biomet, Inc.
56 E. Bell Dr.
P.O. Box 587
Warsaw,  IN  46582
Applicant Contact ALLISON K KOSKEY
Correspondent
Biomet, Inc.
56 E. Bell Dr.
P.O. Box 587
Warsaw,  IN  46582
Correspondent Contact ALLISON K KOSKEY
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWZ   LZO   MEH  
Date Received08/18/2005
Decision Date 11/23/2005
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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