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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 K023186
Device Name OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Applicant Contact MARTIN SPRUNCH
Correspondent
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Correspondent Contact MARTIN SPRUNCH
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/24/2002
Decision Date 10/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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