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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 K020580
Device Name X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
Applicant
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581 -0587
Applicant Contact PATRICIA S BERES
Correspondent
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581 -0587
Correspondent Contact PATRICIA S BERES
Regulation Number888.3358
Classification Product Code
LPH  
Date Received02/21/2002
Decision Date 03/22/2002
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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