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510(k) Data Aggregation

    K Number
    K963398
    Device Name
    ALTA FULLY THREADED CROSS-LOCKING SCREWS
    Manufacturer
    HOWMEDICA CORP.
    Date Cleared
    1996-10-10

    (42 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K850441,K922266,K926232,K935295,K960524,K884500,K890936,K954554
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Alta® Fully Threaded Cross-Locking Screws are intended to be used in conjunction with the Alta® Femoral and Alta® Tibial/ Humeral Intramedullary Rod Systems. Specifically, the screws are used to lock the IM rods in position after placement in the femoral canal.

    Device Description

    The fully threaded screws are manufactured from a Titanium alloy and are available in 5.0mm and 3.7mm diameters in lengths of 25 to 100mm.

    AI/ML Overview

    The provided text describes a 510(k) summary for a medical device, the Alta® Fully Threaded Cross-Locking Screws. This document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for lower-risk medical devices. It does not contain information about acceptance criteria, device performance studies, or AI-related evaluations.

    Therefore, I cannot provide the requested information as it is not present in the input text.

    The input document is a 510(k) summary, which is a regulatory submission for medical devices to demonstrate substantial equivalence to a legally marketed predicate device. Such summaries typically do not include detailed performance studies with acceptance criteria, ground truth establishment, or AI-related metrics like those requested.

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