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510(k) Data Aggregation

    K Number
    K160982
    Device Name
    Sphynx™
    Manufacturer
    Date Cleared
    2016-12-22

    (259 days)

    Product Code
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eden Spine LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The antero-lateral plate Sphynx™ is designed for use during surgery on the thoraco-lumbar area of the spine (T1-L5). The device is to be used only on one side and placed in such a manner as to be as far away from blood vessels and nerve roots as possible. This implant is intended to provide stabilization until a solid spinal fusion develops, in the treatment of the following indications: - Tumor of the vertebral body - Fracture of the anterior spine (trauma) - Degenerative disc disease, compatible with a ventral approach (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) - Pseudoarthrosis - Spondylolysis - Spondylolisthesis - Scoliosis - Lordotic deformities of the spine - Spinal stenosis - Failed previous spine surgery
    Device Description
    The Sphynx is an implant device made from a titanium alloy Ti-6AI-4V ELI. It is to be implanted from the anterior-lateral approach. The Sphynx™ implant is an antero-lateral plate aimed at performing internal fixation of the thoraco-lumbar area of the spine (T1-L5), in addition to a solid intervertebral arthrodesis. The Sphynx™ instrumentation is composed of plates with anatomical conformation for cyphosis and lordosis. These plates are available in lengths 45-135mm increasing increments of 10mm. The fixation screws also consist of a variety of lengths and diameters. The safety screw is a 5mm diameter screw available in lengths starting at 24mm increasing in increments of 5mm to an overall length of 55mm. The two other fixation screws are available in diameters of 6mm and 7mm starting at 25mm and increasing in increments of 5mm to an overall length of 60mm.
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