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510(k) Data Aggregation

    K Number
    K103383
    Device Name
    SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
    Date Cleared
    2011-02-17

    (91 days)

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

    SPARTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is intended for immobilization and stabilization of the thoracic, lumbar, and sacral spine in skeletally mature patients as an adjunct to fusion with autogenous bone graft 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.
    Device Description
    The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is a single use device for monoand multi-segmented stabilization of the lumbar and thoracic vertebrae to facilitate fusion, per the indications for use. The system consists of post and fixed head screws, washers, rods, set screws, and locking nuts.
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    K Number
    K094002
    Device Name
    SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
    Date Cleared
    2010-05-07

    (130 days)

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

    SPARTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is intended for immobilization and stabilization of the thoracic, lumbar, and sacral spine in skeletally mature patients as an adjunct to fusion with autogenous.bone graft 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
    Device Description
    The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is a single use device for mono- and multi-segmented stabilization of the lumbar and thoracic vertebrae to facilitate fusion, per the indications for use. The system consists of post and fixed head screws, washers, rods, set screws, and locking nuts.
    Ask a Question

    Ask a specific question about this device

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