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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, Porous Uncemented
510(k) Number K920831
Device Name PCA TOTAL HIP SYSTEM (CEMENTLESS USE)
Applicant
Pfizer Hospital Products Group, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact ROBERT SMITH
Correspondent
Pfizer Hospital Products Group, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact ROBERT SMITH
Regulation Number888.3358
Classification Product Code
LPH  
Date Received02/20/1992
Decision Date 06/10/1992
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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