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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 K955386
Device Name CONSENSUS ZIRCONIA FEMORAL HEAD
Applicant
U.S. Medical Products, Inc.
12201 Technology Blvd., #100
Austin,  TX  78727
Applicant Contact WILLIAM N THOMPSON
Correspondent
U.S. Medical Products, Inc.
12201 Technology Blvd., #100
Austin,  TX  78727
Correspondent Contact WILLIAM N THOMPSON
Regulation Number888.3353
Classification Product Code
LZO  
Date Received11/22/1995
Decision Date 02/20/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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