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510(k) Data Aggregation

    K Number
    K142041
    Device Name
    POROSTEON PHUSION METAL CERVICAL CAGE
    Manufacturer
    POROSTEON, INC.
    Date Cleared
    2014-12-19

    (144 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    POROSTEON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Phusion Metal Cervical Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Phusion Metal Cervical Cage is intended for use at one level in the cervical spine, from C3 to C7, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Phusion Metal Cervical Cage is to be used in patients who have had six weeks of non-operative treatment. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.
    Device Description
    The Phusion Metal Cervical Cage is an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. The Phusion Metal Cervical Cage is anatomically shaped with two holes in the anterior end of the device each having a diameter of two millimeters extending to the inner cavity. The Phusion Metal Cervical Cage is manufactured from a porous titanium-nickel (Ti-Ni) intermetallic material. The Phusion Metal Cervical Cage is offered in a variety of shapes and sizes to accommodate variations in patient anatomy. The superior and inferior surfaces of the device has a pattern of teeth to provide increased stability and inhibit movement of the implants. Phusion Metal Cage implants are available in one lordotic configuration of 7°and heights ranging from 5 to 10 mm in 1 mm increments. The Phusion Metal Cage device is single-use only.
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