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510(k) Data Aggregation

    K Number
    K233800
    Device Name
    Vertos mild Device Kit (MDK-0002)
    Manufacturer
    Vertos Medical Inc
    Date Cleared
    2024-05-06

    (159 days)

    Product Code
    HRX, CLA, HAE
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vertos Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vertos Medical mild Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.
    Device Description
    The Vertos Medical mild Device Kit is a sterile, single-use device. The mild Device is composed of surgical tools consisting of one each of the following components: mild Initiator, mild Access Auger, mild Bone Rongeur, and mild Tissue Sculpter. The mild Initiator is pre-assembled for convenience and includes: the mild Trocar and Handle, mild Portal, mild Portal Grip, and mild Depth Guide. The mild Device Kit is utilized for tissue access, retraction, and resection within the lumbar spine via a minimally invasive posterior approach. The procedure is conducted percutaneously with the mild Tissue Sculpter and Bone Rongeur, placed through an introducer cannula, the mild Portal.
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