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510(k) Data Aggregation

    K Number
    K251896

    Validate with FDA (Live)

    Device Name
    XeliteMed SuperM-Fix Spinal Bone Cement
    Manufacturer
    Xelite Biomed , Ltd.
    Date Cleared
    2026-01-28

    (222 days)

    Product Code
    NDN
    Regulation Number
    888.3027
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K241775
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    XeliteMed SuperM-Fix Spinal Bone Cement is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).

    Device Description

    XeliteMed SuperM-Fix Spinal Bone Cement is provided as a two component system. The powder component consists of a PMMA-styrene copolymer with barium sulphate and hydroxyapatite as radiopacifiers and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.

    AI/ML Overview

    N/A

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