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510(k) Data Aggregation

    K Number
    K051959
    Device Name
    NV CORMED SOLAS SPINAL SYSTEM
    Manufacturer
    Date Cleared
    2005-10-12

    (86 days)

    Product Code
    Regulation Number
    888.3070
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    Applicant Name (Manufacturer) :

    NV CORMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CORMED NV , SOLAS™, Spinal System is a 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 (15 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the SOLAS™ 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 turnor and failed previous fusion (pseudoarthrosis). When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the SOLAS™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
    Device Description
    The SOLAS™ Spinal System is a top-loading anterior / posterior spinal fixation system which consists of Mono and Polyaxial pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The SOLAS™ implant components are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. The SOLAS'" Spinal system can be used in both the anterior and posterior planes providing unilateral and bilateral modes of fixation. The SOLAS™ design allows adjustment in both the saggital and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a preassembled washer in the housing component between the screw and the rod which tightens against the head of the pedicle screw upon connection of the set screw with the rod. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the SOLASTM implants.
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