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510(k) Data Aggregation

    K Number
    K181471
    Device Name
    ACCUFUSE Cervical System
    Date Cleared
    2018-08-29

    (86 days)

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

    Absolute Advantage Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ACCUFUSE Cervical System (intervertebral body fusion device) is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACCUFUSE Cervical System implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACCUFUSE Cervical System implants are to be used with supplemental fixation. Patients should have at least six weeks of nonoperative treatment prior to surgery. The ACCUFUSE Cervical System (cervical plate/screws) is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spimal fusion in patients with: •degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), •spondylolisthesis, •trauma (i.e. fractures or dislocations), •tumors, •deformity (defined as kyphosis, lordosis, or scoliosis), •pseudarthrosis, •failed previous fusion, •spinal stenosis
    Device Description
    The ACCUFUSE Cervical System consists of intervertebral body fusion devices along with cervical plates and screws used to maintain disc space distraction in skeletally mature adults requiring an intervertebral body fusion. It is designed to be used in conjunction with supplemental spinal fixation instrumentation. The implant is available in a range of footprints and heights to suit each individual's pathology and anatomical conditions of the patient. The implant has a hollow center to allow placement of autogenous bone graft to promote intervertebral body fusion. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent implant migration and/or expulsion. The ACCUFUSE Anterior Cervical Plate is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths addressing single level and two levels of fixation.
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