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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K935696
Device Name ETEX HA HIP REPLACEMENT SYSTEM
Applicant
Etex Corp.
38 Sidney St., 3flr
The Clark Bldg.
Cambridge,  MA  02139
Applicant Contact DOSUK D LEE
Correspondent
Etex Corp.
38 Sidney St., 3flr
The Clark Bldg.
Cambridge,  MA  02139
Correspondent Contact DOSUK D LEE
Regulation Number888.3353
Classification Product Code
MEH  
Date Received11/30/1993
Decision Date 07/22/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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