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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, Hemi-, Femoral, Metal
510(k) Number K965198
Device Name ULTIMA TPS CEMENTED STEM
Applicant
Johnson & Johnson International
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact JANET JOHNSON
Correspondent
Johnson & Johnson International
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact JANET JOHNSON
Regulation Number888.3360
Classification Product Code
KWL  
Subsequent Product Code
JDI  
Date Received12/26/1996
Decision Date 07/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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