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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, Constrained, Cemented Or Uncemented, Metal/Polymer
510(k) Number K071059
Device Name DEPUY SPA POROUS COATED PROXIMAL SLEEVE
Applicant
DePuy Orthopaedics, Inc.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact KATHY HARRIS
Correspondent
DePuy Orthopaedics, Inc.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact KATHY HARRIS
Regulation Number888.3310
Classification Product Code
KWZ  
Subsequent Product Codes
LPH   LZO   MEH  
Date Received04/16/2007
Decision Date 11/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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