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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K935452
Device Name P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
Applicant
Johnson & Johnson Orthopaedics, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact MARSHA J STONE
Correspondent
Johnson & Johnson Orthopaedics, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact MARSHA J STONE
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
LPH  
Date Received11/12/1993
Decision Date 10/06/1994
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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