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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/Polymer, Cemented Or Uncemented
510(k) Number K945518
Device Name P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
Applicant
Johnson & Johnson Professionals, Inc.
P.O. Box 386
King Of Prussia,  PA  19406
Applicant Contact J T DORRIETY
Correspondent
Johnson & Johnson Professionals, Inc.
P.O. Box 386
King Of Prussia,  PA  19406
Correspondent Contact J T DORRIETY
Regulation Number888.3390
Classification Product Code
KWY  
Date Received11/09/1994
Decision Date 03/08/1996
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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