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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 K042252
Device Name NEXFLEX TOTAL HIP SYSTEM
Applicant
Alphatec/Nexmed
6110 Corte Del Cedro
Carlsbad,  CA  92009
Applicant Contact ELLEN A YARNALL
Correspondent
Alphatec/Nexmed
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 Received08/20/2004
Decision Date 12/06/2004
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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