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510(k) Data Aggregation

    K Number
    K090477
    Device Name
    ALPINE PEDICLE SCREW SYSTEM
    Manufacturer
    SANACOR
    Date Cleared
    2009-07-27

    (153 days)

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

    SANACOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alpine Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudoarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.
    Device Description
    The Alpine Pedicle Screw System is a spinal system that consists of screws, rods, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using a posterior approach.
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    K Number
    K073500
    Device Name
    ACTIVE ANTERIOR CERVICAL PLATE SYSTEM
    Manufacturer
    SANACOR
    Date Cleared
    2008-07-03

    (203 days)

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

    SANACOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Active "10 Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-11) with removal of the implants after the attainment of a solid fusion mass. The Active ™ Anterior Cervical Plate System is intended for use under the following indications: · Degenerative disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - · Spondylolisthesis - · Trauma (i.e., fracture or dislocation) - · Spinal stenosis - · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) • Tumor • Pseudoarthrosis - · Failed previous fusion
    Device Description
    The Active " Anterior Cervical Plate System is a fixation system designed to allow for settling of the bone graft during fusion. Plates are provided in various lengths to accommodate fusions from 1 to 4 Ievels. Fixed and variable angle locking unicortical screws are provided in lengths of 12, 14, 16, and 18mm and diameters of 4mm and 4.5mm.
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    K Number
    K070933
    Device Name
    LOWTOP PEDICLE SCREW SYSTEM
    Manufacturer
    SANACOR
    Date Cleared
    2007-06-13

    (71 days)

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

    SANACOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LowTop Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudoarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion. The LowTop System is intended for posterior, non-cervical pedicle fixation for the following indications: Spondylolisthesis Trauma (i.e., fracture or dislocation) Spinal stenosis Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) Tumor Pseudoarthrosis Failed previous fusion In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.
    Device Description
    The LowTop Pedicle Screw System is a spinal system that consists of screws, rods, connectors and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using a posterior approach.
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