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510(k) Data Aggregation

    K Number
    K974720
    Device Name
    HOWMEDICA(R) FULLY THREADED SCREWS
    Manufacturer
    HOWMEDICA, INC.
    Date Cleared
    1998-03-13

    (85 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Howmedica® 3.7mm Fully Threaded Screws are intended to be used for crosslocking of Howmedica's intramedullary nails and IM rods.

    Device Description

    Howmedica's Locking Nail Systems consist of different types of intramedullary nails/rods, cross-locking screws and end caps. This line extension is to add a smaller cross-locking screw for use with current Howmedica® IM rod and nail systems cleared under various 510(k) notifications plus any future styles of stainless steel IM rods or nails. The new screw is 3.7mm in diameter and is available in various lengths. It has a cortical buttress thread design for cross-locking of IM nails. The screws are manufactured from medical grade stainless steel.

    AI/ML Overview

    This 510(k) summary describes a medical device, not an AI/ML diagnostic. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, and expert ground truth is not applicable in the context of an AI/ML device.

    The document discusses the substantial equivalence of Howmedica's Fully Threaded Screws to legally marketed predicate devices based on intended use, materials, design, and operational principles. It is a traditional medical device submission for a physical implant, not a software-based diagnostic tool.

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