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510(k) Data Aggregation

    K Number
    K991732
    Device Name
    CENTRAFIX EXTERNAL FIXATOR
    Manufacturer
    OWANDAR MEDICAL LTD
    Date Cleared
    1999-05-21

    (0 days)

    Product Code
    JEC,AND,HTY
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fixation of orthopaedic fractures to long bones and the pelvis involving severe trauma with loss or damage to soft tissues, infection and/or loss of bone stock.

    Device Description

    Centrafix® External Fixator

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "Centrafix® External Fixator." This document is a regulatory approval letter and does not contain information about the acceptance criteria, device performance, or any studies conducted.

    Therefore, I cannot extract the requested information. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device.

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