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510(k) Data Aggregation

    K Number
    K253854

    Validate with FDA (Live)

    Device Name
    MONTAGE XT Cranial Cement
    Manufacturer
    Abyrx, Inc.
    Date Cleared
    2026-01-02

    (30 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Type
    Special
    Panel
    Neurology
    Age Range
    18 - 120
    Reference & Predicate Devices
    K233566,K221933
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MONTAGE XT Cranial Cement is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts, and other cranial defects with a surface area no larger than 25 cm². MONTAGE XT Cranial Cement should be used only in skeletally mature individuals.

    Device Description

    MONTAGE XT Cranial Cement is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The MONTAGE XT Cranial Cement comprises of two separate components of putty consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE XT Cranial Cement form a putty-like material. The resulting hardened, resorbable material is primarily calcium phosphate and is slowly resorbed during the remodeling process. Montage XT components must be mixed immediately prior to use.

    AI/ML Overview

    N/A

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