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510(k) Data Aggregation

    K Number
    K023119
    Device Name
    BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2002-12-18

    (90 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K043145
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bi-Cortical Bio-Post and Washer is intended as an anchor device for suture or to secure soft tissue directly to bone.

    Device Description

    Arthrex, Inc. Bio-Post and Washer is intended for suture fixation or securing soft tissue to bone. The Bio-Post and Washer is composed of poly(I-lactide) acid, PLLA which is biodegradable and biocompatible. It is 35 mm in length and 6.5 mm wide at the head of the Bio-Post. The addition of the washer increases the diameter to 16.5 mm.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Bi-Cortical Bio-Post and Washer) and does not contain information about acceptance criteria, device performance studies, or AI/software. It details the device's intended use, description, and claims of substantial equivalence to predicate devices based on regulatory requirements.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or AI performance. The document focuses on regulatory approval rather than clinical or technical performance studies.

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