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510(k) Data Aggregation

    K Number
    K991037
    Device Name
    EUCLID REDUCTION AND GUIDANCE SYSTEM
    Manufacturer
    MODULAR CUTTING SYSTEMS, INC.
    Date Cleared
    1999-06-23

    (86 days)

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

    The Euclid Reduction and Positioning System is an adjunct to any intramedullary rod to aid in both the reduction of a femur fracture and to aid in the targeting of the distal screws placed across the rod. It is considered to aid in any type femur fracture for which intramedullary rod fixation is indicated.

    Device Description

    Not Found

    AI/ML Overview

    I am unable to assist with this request. The provided text is a letter from the FDA regarding a medical device, but it does not contain the information needed to answer the questions about acceptance criteria and a study proving device performance. The letter only states that the device is substantially equivalent to previously marketed devices.

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