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510(k) Data Aggregation

    K Number
    K113303
    Device Name
    OSLEOBRIDGE IDSF SPACER CONECTOR
    Manufacturer
    MERETE MEDICAL GMBH
    Date Cleared
    2011-12-09

    (30 days)

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

    OSLEOBRIDGE IDSF SPACER CONECTOR

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

    The device is intended to be used in the management of segmental diaphyseal bone loss of either humerus or tibia or femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.

    Device Description

    OsteoBridge® IDSF Intramedullary Diaphyseal Segmental Defect Fixation Rod System

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. The document appears to be an FDA 510(k) clearance letter for a medical device, the OsteoBridge® IDSF Intramedullary Diaphyseal Segmental Defect Fixation Rod System, outlining its regulatory classification and indications for use. It does not include any performance study data as would be found in a clinical or validation report.

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