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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 31 Results
ProductCode: JWH Applicant: EXACTECH, INC. Decision Date To: 02/08/2023
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truliant porous tibial tray and exactech alteon bone screws Exactech, Inc. K182346 11/26/2018
truliant porous femoral components Exactech, Inc. K181794 09/28/2018
tecres spacer-k temporary knee prosthesis EXACTECH, INC. K032522 05/28/2004
optetrak total knee system, straight stem extensions - additional sizes EXACTECH, INC. K012251 07/31/2001
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 size 0/1 delta (line extension) EXACTECH, INC. K011976 07/16/2001
optetrak total knee system offset tibial tray EXACTECH, INC. K023186 10/17/2002
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 logic total knee system trapezoidal tibial tray, sizes 2.5f/1.5t-3.5f/4.5t EXACTECH, INC. K093360 01/11/2010