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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, Uncemented
510(k) Number K962034
Device Name SC, CEMENTLESS HIP SYSTEM
Applicant
ARTOS MEDICAL PRODUCTS GMBH
CASTLEWAY DRIVE WEST,SUITE 236
INDIANAPOLIS,  IN  46250
Applicant Contact DOUGLAS W STUART
Correspondent
ARTOS MEDICAL PRODUCTS GMBH
CASTLEWAY DRIVE WEST,SUITE 236
INDIANAPOLIS,  IN  46250
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3360
Classification Product Code
LWJ  
Subsequent Product Code
JDI  
Date Received05/24/1996
Decision Date 10/23/1996
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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