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510(k) Data Aggregation

    K Number
    K062686
    Device Name
    UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM
    Manufacturer
    ADVANCED SPINE TECHNOLOGY, INC.
    Date Cleared
    2006-10-05

    (27 days)

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

    ADVANCED SPINE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Universal Spinal Anterior Locking Plate System is intended for anterior/anterolateral fixation for the following indications: - degenerative disc disease (DDD) (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, and/or lordosis); - tumor; - pseudoarthrosis; - and failed previous fusion. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
    Device Description
    The USA Locking Plate System consists of a multiple sized plates and screws. All components are fabricated from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136 Fixation is provided by inserting screws through holes in the plate into the vertebral bodies of the thoraco-lumbar and lumbar spine. The bone plates offer slotted and round holes that allow the bone screws to be located and securely seated in various positions. There are two plate configurations available: the straight locking plate and the narrow locking plate. The screws include the universal locking screw, the self locking screw and the cancellous locking screw.
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    K Number
    K993066
    Device Name
    WINDOW CERVICAL DYNAMIC PLATE SYSTEM
    Manufacturer
    ADVANCED SPINE TECHNOLOGY, INC.
    Date Cleared
    2000-06-07

    (349 days)

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

    ADVANCED SPINE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Window Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and /or failed previous fusions.
    Device Description
    The Window Cervical Plate System is a set of implants designed to be implanted via an anterior approach to the cervical spine. The system includes various plates and screws manufactured from Titanium. The material used in the manufacture of the components in the Window Cervical System meets ASTM F136 for Ti 6A1-4VELI.
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    K Number
    K992147
    Device Name
    TRIPLE-FIX SPINAL FIXATION SYSTEM
    Manufacturer
    ADVANCED SPINE TECHNOLOGY, INC.
    Date Cleared
    2000-02-28

    (249 days)

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

    ADVANCED SPINE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Triple-Fix Spinal System is a pedicle screw system 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 spondylolithesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudoarthrosis). The posterior Triple-Fix Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1. The posterior Triple-Fix System, when not used with pedicle screws is indicated for hook, wire, and /or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.
    Device Description
    The Advanced Spine Technology Triple-Fix Spinal System is a system that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, plates, and accessory connection components.
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