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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 K051976
Device Name PROVEN REVISION MODULAR TIBIAL TRAY
Applicant
STELKAST COMPANY
200 HIDDEN VALLEY RD.
MCMURRAY,  PA  15317
Applicant Contact DONALD A STEVENS
Correspondent
STELKAST COMPANY
200 HIDDEN VALLEY RD.
MCMURRAY,  PA  15317
Correspondent Contact DONALD A STEVENS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/21/2005
Decision Date 10/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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