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510(k) Data Aggregation

    K Number
    K232607
    Device Name
    4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
    Date Cleared
    2024-02-27

    (183 days)

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

    Solco Biomedical Copany India Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are the pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-Sl 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. The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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, spinal tumor and failed previous fusion (pseudarthrosis ). aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are intended to used for Minimal Invasive Surgery (MIS).
    Device Description
    The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, and nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) and Cobalt Chromium ally that conforms to ASTM F136 and ASTM F1537 respectively. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.
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