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510(k) Data Aggregation

    K Number
    K153525
    Device Name
    Seneka II Polyscrew Pedicle Fixation System
    Manufacturer
    Date Cleared
    2016-01-28

    (50 days)

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

    Senecka Spine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Seneka II Polyscrew Pedicle Fixation System is intended for posterior non-cervical fixation as an adjunct to fusion in skeletally mature patients 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); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Seneka II Polyscrew Pedicle Fixation System may also be used for the same indications as an adjunct to fusion.
    Device Description
    The Seneka II Polyscrew Pedicle Fixation System is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, reduction screws, domino connectors, offset connectors, hooks and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Seneka II system can be implanted via the open surgical approach. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, cobalt chrome per ASTM F1537 or CP Titanium per ASTM E2371-13.
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    K Number
    K151849
    Device Name
    Seneka I Polyscrew Pedicle Fixation System
    Manufacturer
    Date Cleared
    2015-09-30

    (85 days)

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

    Senecka Spine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Seneka I Polyscrew Pedicle Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft 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 Seneka I Polyscrew Pedicle Fixation System is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, reduction screws, domino connectors, offset connectors and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Seneka I system can be implanted via the open surgical approach. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, cobalt chrome per ASTM F1537 or CP Titanium per ASTM E2371-13.
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