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510(k) Data Aggregation

    K Number
    K972813
    Device Name
    GAMMA LOCKING NAIL SYSTEM
    Manufacturer
    HOWMEDICA CORP.
    Date Cleared
    1997-10-09

    (72 days)

    Product Code
    HSB,FOR
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GAMMA LOCKING NAIL SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.

    Device Description

    The Gamma® Locking Nail System consist of a family of femoral nails, lag screws set screws rno cap screws for intramedullary nailing of proximal femoral fractures. This line extension is a and ouplification of the currently marketed Gamma nails cleared under various 510(k) notifications. mounter, or the builter, rounder nails will retain the major design features of the previously cleared Gamma nails and will be made from Orthinox® stainless steel.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

    The document is a 510(k) summary for a Gamma® Locking Nail System line extension. It primarily focuses on demonstrating substantial equivalence to previously marketed devices, rather than presenting a detailed performance study with acceptance criteria.

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