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510(k) Data Aggregation

    K Number
    K193256
    Device Name
    Anjon Bremer Halo System
    Manufacturer
    Anjon Holdings LLC
    Date Cleared
    2020-03-02

    (97 days)

    Product Code
    JEC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anjon Holdings LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.
    Device Description
    The Anjon Bremer Halo System consists of transcutaneous bone anchorage elements. and extracutaneous bridge elements, which provide fixation of the skull relative to the torso to immobilize the cervical spine when used with a frame or surgical table adaptor. The transcutaneous bone anchorage elements are titanium threaded skull pins. of which four (4) skull pins attach to an aluminum crown or ring positioned below the head equator. The crown or ring is then attached to an aluminum rod superstructure, which is attached to a lined polymer vest, or attached to a surgical table using the Mayfield adaptor. Fixation of the selected bridge element (crown or ring) to the patient skull is accomplished using tight connection of the titanium threaded skull pins up to a maximum specified torque. The head is then held in extension when the frame (vest and superstructure) are connected to the bridge element, at which time reduction occurs. For rigid support during diagnostic examination or surgical procedure, the bridge element can be connected to the surgical table through use of the Mayfield adaptor. Cervical spine immobilization and therapeutic traction occurs as localized rotation and flexion motion is eliminated.
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