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510(k) Data Aggregation

    K Number
    K020611
    Device Name
    UNIVERSAL BONE PLATE III SYSTEM (UBP III)
    Manufacturer
    SPINAL CONCEPTS, INC.
    Date Cleared
    2002-03-27

    (30 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K973586
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The UBP System III is intended to bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist, and hand.

    Device Description

    The UBP III System consists of single and multi-segmented titanium bone plates of various sizes and lengths, titanium bone screws in 3.5 and 4.0mm diameters and various lengths, and associated instrumentation. Fixation is provided by the insertion of bone screws through the openings in the plate.

    AI/ML Overview

    The provided document is a 510(k) summary for the Universal Bone Plate III System. It describes a medical device, and the information requested pertains to the evaluation of AI/ML-based medical devices. This document does not contain any information related to AI/ML or a study proving that an AI/ML device meets acceptance criteria.

    Therefore, I cannot fulfill the request using the provided text. The document focuses on the mechanical testing of a bone plate system to demonstrate substantial equivalence to a predicate device, which is a different type of evaluation from the one described in the prompt.

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