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510(k) Data Aggregation

    K Number
    K082399
    Device Name
    PECTUS STRUT
    Manufacturer
    KOROS USA, INC.
    Date Cleared
    2009-11-05

    (442 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PECTUS STRUT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Device is intended for use in surgical procedures to repair Pectus Excavatum and sternal deformities.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a study to prove acceptance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details. The document is an FDA 510(k) clearance letter for the Adkins-Fonkalsrud Pectus Excavatum Strut, which confirms the device's substantial equivalence to a legally marketed predicate device. It outlines regulatory information but does not include any performance study details as requested.

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