Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K171863
    Device Name
    Anjon Bremer Halo System
    Manufacturer
    Anjon Holdings, LLC
    Date Cleared
    2018-03-19

    (270 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 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. All materials are MRI/CT conditional.
    Ask a Question

    Page 1 of 1