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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 Uncemented Acetabular Component)
510(k) Number K850840
Device Name HOWMEDICA THREADED ACETABULAR COMPONENT
Applicant
Pfizer, Inc.
235 E. 42nd St.
Ny,  NY  10017
Applicant Contact RONALD DUCHENE
Correspondent
Pfizer, Inc.
235 E. 42nd St.
Ny,  NY  10017
Correspondent Contact RONALD DUCHENE
Regulation Number888.3330
Classification Product Code
KWA  
Date Received03/01/1985
Decision Date 07/15/1985
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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