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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K954818
Device Name CONSENSUS POSTERIOR STABILIZED KNEE
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 Number888.3560
Classification Product Code
JWH  
Date Received10/20/1995
Decision Date 05/22/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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