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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 K033580
Device Name NEXFLEX TOTAL HIP SYSTEM
Applicant
Nexmed, Inc.
6110 Corte Del Cedro
Carlsbad,  CA  92009
Applicant Contact ELLEN A YARNALL
Correspondent
Nexmed, Inc.
6110 Corte Del Cedro
Carlsbad,  CA  92009
Correspondent Contact ELLEN A YARNALL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWY  
Date Received11/13/2003
Decision Date 08/05/2004
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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