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510(k) Data Aggregation

    K Number
    K980689
    Device Name
    FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
    Manufacturer
    FRIDDLE'S ORTHOPEDIC APPLIANCES, INC.
    Date Cleared
    1999-02-18

    (360 days)

    Product Code
    HAX
    Regulation Number
    882.5960
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRIDDLE'S ORTHOPEDIC APPLIANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is designed to provide traction and/or to immobilize a patient with a cervical spine injury or after surgery.
    Device Description
    The Friddle Halo system is very similar to several halo systems, which are designed to hold the skull firmly in place relative to the torso so that the cervical vertabrae are immobolized after surgery or injury. The system is comprised of a ring, rods, and braces system made of a carbon fiber-epoxy composite which is placed over a vest made of high-density polyethylene, lined with Kodel or sometimes sheepskin. The skull pins are made of CP titanium. The titanium skull pins, carbon fiber-epoxy composite rods, high-density polyethylene, Kodel, and sheepskin are used throughout the industry.
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