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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 K952088
Device Name ZIRCONIA ARTICUL/EZE FEMORAL BALLS
Applicant
Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact CHERYL K HASTINGS
Correspondent
Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact CHERYL K HASTINGS
Regulation Number888.3353
Classification Product Code
LZO  
Date Received05/03/1995
Decision Date 06/30/1995
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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