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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 K905298
Device Name TITAN TOTAL HIP DEVICE
Applicant
Dr. Jean-Marc Guichet
500 Riverside Dr., #2n
New York City,  NY  10027
Applicant Contact JEAN-MARC GUICHET
Correspondent
Dr. Jean-Marc Guichet
500 Riverside Dr., #2n
New York City,  NY  10027
Correspondent Contact JEAN-MARC GUICHET
Regulation Number888.3350
Classification Product Code
JDI  
Date Received11/27/1990
Decision Date 06/17/1991
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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