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

    NSite Scoliosis Assessment App

    K Number: K230463 · Decision Nov 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    267

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    Basic Information

    Device Name
    NSite Scoliosis Assessment App
    K Number
    K230463
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nsite, Inc.
    Date Received
    February 21, 2023
    Decision Date
    November 15, 2023
    Product Code
    LDK
    Advisory Committee
    Unknown
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LDK Device, Sensing, Optical Contour

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