BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Exactech® TRULIANT® Knee System

    K Number: K240393 · Decision Oct 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    186
    Review Days
    238

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    Basic Information

    Device Name
    Exactech® TRULIANT® Knee System
    K Number
    K240393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exactech, Inc.
    Date Received
    February 8, 2024
    Decision Date
    October 3, 2024
    Product Code
    MBH
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

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    Other Clearances by Exactech, Inc.

    K Number Device Name
    K260583 Equinoxe® Shoulder System
    K250713 Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
    K243448 Equinoxe® Shoulder System
    K243275 Equinoxe® Scapula Fracture System
    K243839 Alteon® HA Femoral Stems
    K233482 Equinoxe® Central Screw Baseplate System
    K230717 Exactech® Vantage® Total Ankle System
    K223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws
    K223833 Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
    K232002 Vantage® Total Ankle System
    Search all 186 clearances from Exactech, Inc. →