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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 K945589
Device Name CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE
Applicant
U.S. Medical Products, Inc.
912 Capital Of Texas Hwy.South
Suite 100
Austin,  TX  78746
Applicant Contact WILLIAN N THOMPSON
Correspondent
U.S. Medical Products, Inc.
912 Capital Of Texas Hwy.South
Suite 100
Austin,  TX  78746
Correspondent Contact WILLIAN N THOMPSON
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/14/1994
Decision Date 05/31/1995
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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