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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K972643
Device Name DEPUY AMK 3 PEG PATELLA
Applicant
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact CHERYL HASTINGS
Correspondent
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact CHERYL HASTINGS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/15/1997
Decision Date 01/21/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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