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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 K100391
Device Name DEPUY UNIVERSAL GRIPTION TF CONES
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact DAWN SINCLAIR, MA
Correspondent
DePuy Synthes
3 Main St.
Ringaskiddy,  IE
Correspondent Contact Jennifer Hill
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
JDI   KRO   LPH   LZO  
Date Received02/16/2010
Decision Date 09/29/2010
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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