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

    OvertureTi Knee Resurfacing SystemTM

    K Number: K242746 · Decision Oct 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    113
    Applicant Total
    1
    Review Days
    26

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    Basic Information

    Device Name
    OvertureTi Knee Resurfacing SystemTM
    K Number
    K242746
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Overture Orthopaedics
    Date Received
    September 11, 2024
    Decision Date
    October 7, 2024
    Product Code
    HSX
    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
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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