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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, Femoral Component, Cemented, Metal
510(k) Number K953653
Device Name LUBINUS SP II HIP SYSTEM
Applicant
TURNKEY INTERGRATION USA, INC.
6060 CASTLEWAY DR. WEST
SUITE 236
INDIANAPOLIS,  IN  46250 -1290
Applicant Contact DOUGLAS W STUART
Correspondent
TURNKEY INTERGRATION USA, INC.
6060 CASTLEWAY DR. WEST
SUITE 236
INDIANAPOLIS,  IN  46250 -1290
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3360
Classification Product Code
JDG  
Date Received08/03/1995
Decision Date 11/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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