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510(k) Data Aggregation

    K Number
    K193211
    Device Name
    Nano FortiFix® System
    Manufacturer
    Nanovis Spine LLC
    Date Cleared
    2020-03-20

    (120 days)

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

    Nanovis Spine LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nano FortiFix® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the non-cervical spine for the following indications: DDD (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion.
    Device Description
    Nano FortiFix® is a posterior pedicle screw system consisting of rods, polyaxial pedicle screws, connectors and fasteners in a variety of sizes to accommodate differing anatomic requirements. The Nano FortiFix® pedicle screw shaft is available with or without a nanosurface. The Nano FortiFix® nano pedicle screw has a micro- and nano-roughened surface that demonstrates the requirements for nanotechnology. The surface of the nano screw threads has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. These threads are electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface.
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    K Number
    K162250
    Device Name
    FortiBridge Anterior Cervical Plate System
    Manufacturer
    NANOVIS SPINE LLC
    Date Cleared
    2016-10-26

    (77 days)

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

    NANOVIS SPINE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
    Device Description
    The FortiBridge™ System consists of implants and instruments for implantation. It is an anterior cervical plate and screw system which includes fixed and variable screws having standard, self-drilling or self-tapping tips, and one- through four-level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient. The devices are sold sterile.
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    K Number
    K143706
    Device Name
    FortiBridge Anterior Cervical Plate System
    Manufacturer
    Nanovis Spine LLC
    Date Cleared
    2015-04-10

    (102 days)

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

    Nanovis Spine LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis or scoliosis), pseudarthrosis or failed previous fusion.
    Device Description
    The FortiBridge™ System consists of implants and instruments for implantation. It is an anterior cervical plate and screw system which includes fixed and variable screws having standard, self-drilling or self-tapping tips, and one- through four-level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.
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