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510(k) Data Aggregation

    K Number
    K962779
    Device Name
    COMPRESSION SCREW
    Manufacturer
    ORTHOPAEDIC BIOSYSTEMS, LTD.
    Date Cleared
    1996-08-23

    (37 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    The proposed device, the small bone screw claims substantial equivalence to a currently marketed device, the Synthes mini-fragment bone screw. The Synthes screws and the proposed device are both available in Titanium and Stainless Steel. Both function as internal fixation for bones and have no significant design differences.

    AI/ML Overview

    The provided text does not contain information about an AI/ML powered device, its acceptance criteria, or a study proving its performance. Instead, it describes a 510(k) summary for a small bone screw claiming substantial equivalence to a predicate device.

    Therefore, I cannot answer your request regarding acceptance criteria and a study for an AI/ML device, as the provided input is irrelevant to that topic.

    The input describes a medical device, a small bone screw, and its claim of substantial equivalence to a predicate device (Synthes mini-fragment bone screw) based on material (Titanium and Stainless Steel) and function (internal fixation for bones) with no significant design differences. This is a common process for regulatory clearance of traditional medical devices, not AI/ML driven ones.

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