BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Anjon Bremer Halo System

    K Number: K193256 · Decision Mar 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    84
    Applicant Total
    2
    Review Days
    97

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    Basic Information

    Device Name
    Anjon Bremer Halo System
    K Number
    K193256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anjon Holdings, LLC
    Date Received
    November 26, 2019
    Decision Date
    March 2, 2020
    Product Code
    JEC
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JEC Component, Traction, Invasive

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    Other Clearances by Anjon Holdings, LLC

    K Number Device Name
    K171863 Anjon Bremer Halo System