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

    Augment Off-Axis Instrument System

    K Number: K241043 · Decision May 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    203
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    Augment Off-Axis Instrument System
    K Number
    K241043
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fix Surgical
    Date Received
    April 17, 2024
    Decision Date
    May 15, 2024
    Product Code
    PHX
    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
    PHX Shoulder Prosthesis, Reverse Configuration

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    Other Clearances by Fix Surgical

    K Number Device Name
    K233148 Augment Off-Axis Instrument System