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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, femorotibial, semi-constrained, cemented, metal/polymer
510(k) Number K040889
Device Name EXACTECH OPTETRAK UNICONDYLAR KNEE
Original Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville,  FL  32653
Original Contact gary miller
Regulation Number888.3530
Classification Product Code
HRY  
Date Received04/05/2004
Decision Date 10/01/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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