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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 K955170
Device Name NEXFLEX FEMORAL STEM, STANDARD DESIGN
Applicant
Nexmed, Inc.
42-160 State St.
Palm Desert,  CA  92211
Applicant Contact REBECCA H WAHL
Correspondent
Nexmed, Inc.
42-160 State St.
Palm Desert,  CA  92211
Correspondent Contact REBECCA H WAHL
Regulation Number888.3358
Classification Product Code
LPH  
Date Received11/13/1995
Decision Date 02/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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