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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, Cemented
510(k) Number K023085
Device Name RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
Applicant
Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact DALENE T BINKLEY
Correspondent
Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact DALENE T BINKLEY
Regulation Number888.3350
Classification Product Code
JDI  
Date Received09/17/2002
Decision Date 10/17/2002
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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