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510(k) Data Aggregation

    K Number
    K042713
    Device Name
    FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
    Manufacturer
    SPINE NEXT AMERICA CORPORATION
    Date Cleared
    2004-12-29

    (90 days)

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

    SPINE NEXT AMERICA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FIDJI type 5 is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to turnor or trauma (i.e., fracture). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. This device is intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System. Additionally, FIDJI type 5 is intended to be used in a paired configuration.
    Device Description
    The Spine Next FIDJI Vetebral Body Replacement Type 5 devices are hollow blocks that are machined from extruded Polyetheretherketone (PEEK); the blocks are tapered to aid in maintaining lordosis of the spine following implantation. The devices have angled teeth on the cephalad and caudal surfaces. The devices include tantalum inserts that serve as a location and orientation markers for radiographs.
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    K Number
    K042714
    Device Name
    FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4
    Manufacturer
    SPINE NEXT AMERICA CORPORATION
    Date Cleared
    2004-12-29

    (96 days)

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

    SPINE NEXT AMERICA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FIDJI types 1, 2, 3, and 4 are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System.
    Device Description
    The FIDJI Vertebral Body Replacement Types 1, 2, 3, and 4 devices are hollow blocks that are machined from PEEK OPTIMA® (polyetheretherketone, ASTM F2026); the blocks are tapered to aid in maintaining lordosis of the spine following implantation. The devices have angled teeth on the cephalad and caudal surfaces. The devices include tantalum inserts that serve as a location and orientation markers for radiographs.
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