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510(k) Data Aggregation

    K Number
    K191786
    Device Name
    Cyclops™ Anterior Cervical Plate System
    Manufacturer
    DeGen Medical INC
    Date Cleared
    2019-08-30

    (58 days)

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

    DeGen Medical INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DeGen Medical Cyclops™ Anterior Cervical Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™ Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications: - · Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - Spinal Stenosis . - Trauma (i.e. fracture or dislocation) . - Deformity or curvatures (including scoliosis, kyphosis, or lordosis) . - . Spinal Tumors - Pseudoarthrosis or failed previous fusion . - Spondylolisthesis . - Decompression of the spinal following total or partial cervical vertebrectomy .
    Device Description
    The DeGen Medical Cyclops™ Anterior Cervical Plate Systems (CACP) consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The CACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options. The system is provided non-sterile and is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
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