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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 K925895
Device Name ETEX HIP REPLACEMENT SYSTEM
Applicant
Etex Co.
University Park At Mit
38 Sidney St.-The Clark Bldg.
Cambridge,  MA  02139
Applicant Contact DOSUK LEE
Correspondent
Etex Co.
University Park At Mit
38 Sidney St.-The Clark Bldg.
Cambridge,  MA  02139
Correspondent Contact DOSUK LEE
Regulation Number888.3350
Classification Product Code
JDI  
Date Received11/16/1992
Decision Date 02/09/1993
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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