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510(k) Data Aggregation

    K Number
    K090733
    Device Name
    PMT HALO SYSTEM
    Manufacturer
    PMT CORP.
    Date Cleared
    2009-07-28

    (131 days)

    Product Code
    HAX
    Regulation Number
    882.5960
    Why did this record match?
    Product Code :

    HAX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PMT Halo System with Open Back Carbon Graphite and Titanium Skull Pins and the PMT Halo System with Closed Back Carbon Graphite and Titanium Skull Pins provides cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries. The PMT Halo system is MR Conditional and may be used safely in an MRI under the following conditions: - Static magnetic field of 1.5T and 3T only . - Maximum spatial gradient magnetic field of 720 Gauss/cm or less . - Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) ● of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).
    Device Description
    The PMT Halo System is designed for positioning and stabilization of the cervical spine area. It provides optimum external immobilization and traction for the cervical region while allowing the patient to leave the hospital and resume their normal activities. To enhance the magnetic resonance imaging compatibility, the PMT Halo system utilizes non-magnetic titanium skull pins and hardware, brass positioning pins, and advanced non-metallic support materials such as carbon graphite upright bars and composite head fixation subassemblies.
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    K Number
    K071173
    Device Name
    RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
    Manufacturer
    OSSUR AMERICANS (FORMERLY THE JEROME GROUP)
    Date Cleared
    2007-05-25

    (28 days)

    Product Code
    HAX
    Regulation Number
    882.5960
    Why did this record match?
    Product Code :

    HAX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReSolve Tongs are intended for use to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
    Device Description
    The ReSolve Tongs are similar to other traction tongs which are used to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
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    K Number
    K051918
    Device Name
    RESOLVE OPEN BACK HALO RINGS
    Manufacturer
    JEROME MEDICAL
    Date Cleared
    2005-08-17

    (33 days)

    Product Code
    HAX
    Regulation Number
    882.5960
    Why did this record match?
    Product Code :

    HAX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReSOLVE Open Back Halo Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.
    Device Description
    The ReSOLVE Open Back Halo Traction Ring is similar to other rings which, when used as part of a Halo System, are designed to hold the skull immobilized following surgery or injury.
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    K Number
    K023959
    Device Name
    JEROME GLASS RING
    Manufacturer
    THE JEROME GROUP, INC.
    Date Cleared
    2003-02-21

    (86 days)

    Product Code
    HAX
    Regulation Number
    882.5960
    Why did this record match?
    Product Code :

    HAX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jerome Glass Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.
    Device Description
    The Fiberglass Halo Traction Ring is similar to other halo rings which. when used as part of a Halo System, are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized following surgery or injury.
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    K Number
    K003662
    Device Name
    SPINE WORKS COLLAR
    Manufacturer
    SPINE WORKS
    Date Cleared
    2001-07-09

    (223 days)

    Product Code
    HAX
    Regulation Number
    882.5960
    Why did this record match?
    Product Code :

    HAX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    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?
    Product Code :

    HAX

    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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