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510(k) Data Aggregation

    K Number
    K131522
    Device Name
    CORE PEDICLE SCREW SYSTEM
    Manufacturer
    Date Cleared
    2013-08-09

    (73 days)

    Product Code
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORE-NEXUS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Core Pedicle Screw System is a posterior pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the Core Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Core Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); tumor; pseudoarthrosis; and failed previous fusion. The Core Hook System can be used in conjunction with Core Pedicle Screw System.
    Device Description
    The Core Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system that consists of pedicle screws, rods, hooks, set screws, connectors, and a transverse (cross) linking mechanism. The Core Pedicle Screw System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion.
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    K Number
    K131520
    Device Name
    NEXUS ANTERIOR CERVICAL PLATE SYSTEM
    Manufacturer
    Date Cleared
    2013-07-11

    (44 days)

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

    CORE-NEXUS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nexus Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
    Device Description
    The Nexus Anterior Cervical Plate System consists of a variety of shapes and sizes of main plates, screws, sub-plates, rivets and associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion. The rivets are pre-assembled to the main plate, which firmly attach the sub-plate component to the main plate. Each component is color anodized to differentiate the screw type and diameter and to facilitate the surgical process. The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are provided in fixed self-tapping, variable self-tapping, fixed self-drilling and variable self-drilling configurations.
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