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510(k) Data Aggregation

    K Number
    K083178
    Device Name
    SOLAS ANATOMIX SPINAL SYSTEM
    Date Cleared
    2009-02-23

    (118 days)

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

    BIOTECHNI AMERICA SPINE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BASG, Inc., SOLAS AnatomixTM, Spinal System is a modular pedicle screw based spinal fixation 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 sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the SOLAS Anatomix™ 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 and chronic 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). The SOLAS Anatomix™ is intended for anterior/anterolateral and posterior, non-cervical and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as hen' pain of discogenic origin with degeneration of the disc confirmed by history and padiographic studies), spondylolisthesis, trauma (i.e., fracture and/or dislocation) spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion.
    Device Description
    The SOLAS Anatomix Spinal System is a new modular spinal fixation system which can be used for anterior, antereolateral, posterior applications. This system includes screws, housing assemblies, rods, connectors and a cross-link mechanism in conjunction with specialized instruments which facilitate application. All implant components are fabricated from Titanium allov that conforms to ASTM F 136.
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