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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K935453
Device Name CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM
Applicant
U.S. Medical Products, Inc.
912 S. Capital Of Texas Hwy.
Suite 100
Austin,  TX  78746
Applicant Contact STEVEN L WHITLOCK
Correspondent
U.S. Medical Products, Inc.
912 S. Capital Of Texas Hwy.
Suite 100
Austin,  TX  78746
Correspondent Contact STEVEN L WHITLOCK
Regulation Number888.3353
Classification Product Code
MEH  
Date Received11/12/1993
Decision Date 07/13/1994
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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