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510(k) Data Aggregation

    K Number
    K210306
    Device Name
    GII Spinal Fixation System
    Manufacturer
    Date Cleared
    2021-05-19

    (105 days)

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

    Coligne AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Coligne GII Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The GII Spinal Fixation System is intended for use in the non-cervical posterior spine, in skeletally-mature patients, as an adjunct to fusion using autograft and/or allograft, the GII Spinal Fixation System is intended for use or more of the following; (1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal stenosis, (6) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis). When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Coligne GII Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/or trauma. This system is intended to be used with autograft. Pediatic pedicle screw fixation is limited to a posterior approach.
    Device Description
    The GII Spinal Fixation System is a top loading polyaxial pedicle screw, which, when used with rods and crosslinks, results in a multiple component, posterior system. All the components are available in a variety of sizes to match the patient's anatomy more closely.
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