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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 Uncemented Acetabular Component)
510(k) Number K850055
Device Name PROFILE FEMORAL HIP
Applicant
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact STEPHEN M DOYLE
Correspondent
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact STEPHEN M DOYLE
Regulation Number888.3330
Classification Product Code
KWA  
Date Received01/08/1985
Decision Date 04/23/1985
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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