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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    JEROME MEDICAL

    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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