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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, Cemented
510(k) Number K901087
Device Name MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS
Applicant
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact G ROBERTS
Correspondent
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact G ROBERTS
Regulation Number888.3350
Classification Product Code
JDI  
Date Received03/09/1990
Decision Date 05/07/1990
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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