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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, partial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K061648
Device Name DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
Applicant
DEPUY ORTHOPAEDICS, INC.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Applicant Contact NANCY FRIDDLE
Correspondent
DEPUY ORTHOPAEDICS, INC.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Correspondent Contact NANCY FRIDDLE
Regulation Number888.3560
Classification Product Code
NPJ  
Subsequent Product Codes
HRY   KRR  
Date Received06/13/2006
Decision Date 09/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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