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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 K022463
Device Name HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS
Applicant
Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact DALENE T BINKLEY
Correspondent
Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact DALENE T BINKLEY
Regulation Number888.3358
Classification Product Code
LPH  
Date Received07/26/2002
Decision Date 08/16/2002
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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