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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 K935193
Device Name CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM
Applicant
U.S. Medical Products, Inc.
912 S. Capital Of Texas Hwy.
Suite 100
Austin,  TX  78746
Applicant Contact STEVEN I WHITLOCK
Correspondent
U.S. Medical Products, Inc.
912 S. Capital Of Texas Hwy.
Suite 100
Austin,  TX  78746
Correspondent Contact STEVEN I WHITLOCK
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
LPH  
Date Received10/26/1993
Decision Date 08/18/1994
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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