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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 K902137
Device Name P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT
Applicant
Johnson & Johnson Orthopaedics, Inc.
Braintree,  MA  02184
Applicant Contact J STONE
Correspondent
Johnson & Johnson Orthopaedics, Inc.
Braintree,  MA  02184
Correspondent Contact J STONE
Regulation Number888.3350
Classification Product Code
JDI  
Date Received05/11/1990
Decision Date 06/26/1990
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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