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510(k) Data Aggregation

    K Number
    K252546

    Validate with FDA (Live)

    Device Name
    VantageTM Lumbar Decompression Kit
    Manufacturer
    Allevion Medical, LLC
    Date Cleared
    2026-03-12

    (212 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K243774
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VantageTM Lumbar Decompression Kit by Allevion Medical is a specialized set of surgical instruments intended to be used to perform lumbar decompression procedures used in the treatment of various spinal conditions.

    Device Description

    The VantageTM Lumbar Decompression Kit is a sterile, single-use device designed to facilitate lumbar spine decompression procedures. It includes a variety of specialized instruments intended to be used together to access and remove bone and soft tissue during decompression. The kit supports multiple procedural approaches by utilizing different components of the kit. The physician can utilize VantageTM Lumbar Decompression Kit in open, direct visualization or indirect visualization approaches. All kits contain a disposable light source to assist with visualization if desired.

    AI/ML Overview

    N/A

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