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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/Polymer, Porous Uncemented
510(k) Number K953703
Device Name DEPUY VISION SOLUTION HIP PROSTHESIS
Applicant
DEPUY, INC.
P.O. BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Applicant Contact CHERYL HASTINGS
Correspondent
DEPUY, INC.
P.O. BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Correspondent Contact CHERYL HASTINGS
Regulation Number888.3358
Classification Product Code
LPH  
Date Received08/08/1995
Decision Date 02/01/1996
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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