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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 31 Results
ProductCode: JWH Applicant: EXACTECH, INC. Decision Date To: 02/08/2023
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optetrak logic cr tibial insert, optetrak logic cr femoral component EXACTECH, INC. K111400 07/28/2011
optetrak logic combination tibial tray EXACTECH, INC. K101981 08/02/2010
optetrak logic total knee system trapezoidal tibial tray, sizes 2.5f/1.5t-3.5f/4.5t EXACTECH, INC. K093360 01/11/2010
optetrak 9mm cruciate retaining tibial insert, slope ++ EXACTECH, INC. K082022 09/02/2008
exactech optetrak proximal tibial spacer EXACTECH, INC. K071738 08/15/2007
tecres spacer-k temporary knee prosthesis EXACTECH, INC. K032522 05/28/2004
optetrak total knee system, hi-flex asymmetric posterior-stabilized cemented femoral components, hi-flex posterior-stabi EXACTECH, INC. K033883 02/13/2004
optetrak total knee system asymmetric femoral components size 6 psoterior-stabilizing, cemented femoral components EXACTECH, INC. K032606 09/23/2003
optetrak total knee system - molded metal-back tibial component EXACTECH, INC. K030686 04/02/2003
optetrak total knee system offset tibial tray EXACTECH, INC. K023186 10/17/2002