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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 K952859
Device Name ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
ROUTE 202 N.
RARITAN,  NJ  08869
Applicant Contact J. TERESA DORRIETY
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
ROUTE 202 N.
RARITAN,  NJ  08869
Correspondent Contact J. TERESA DORRIETY
Regulation Number888.3350
Classification Product Code
JDI  
Date Received06/22/1995
Decision Date 01/31/1996
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
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