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510(k) Data Aggregation

    K Number
    K180324
    Device Name
    Patriot Spinal Fixation System
    Manufacturer
    Date Cleared
    2018-04-06

    (60 days)

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

    Valorus Spine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Patriot Spinal Fixation System, when used in the non-cervical posterior spine (TI to S1), 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudoarthrosis, and failed previous fusion. In addition, when used placed between L5 and S1, the Patriot Spinal Fixation System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) in skeletally mature patients receiving fusion with autologous bone graft.
    Device Description
    The Patriot Spinal Fixation System is a posterior, non-cervical, spinal fixation system consisting of a variety of shapes and sizes of rods, screws, and crosslinks, to provide temporary internal fixation and stabilization during bone graft healing as an adjunct to fusion of the thoracic, lumbar and sacral spine.
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    K Number
    K172585
    Device Name
    Liberty Anterior Cervical Plate
    Manufacturer
    Date Cleared
    2017-10-23

    (56 days)

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

    Valorus Spine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Liberty Anterior Cervical Plate System is interior screw fixation of the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: - degenerative disc disease (as defined by neck pain of discogenic origin with the degeneration of the disc confirmed by patient history and radiographic studies), - spondylolisthesis. - trauma (i.e. fractures or dislocations), - tumors. - deformity (i.e. kyphosis, lordosis or scoliosis), - pseudarthrosis. - failed previous fusion, - spinal stenosis
    Device Description
    The Liberty Anterior Cervical Plate is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-drilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (10 mm – 100 mm), addressing multiple levels of fixation (one to five). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in two diameters (4.0 mm, and 4.5 mm) and a variety of lengths (10 mm - 18 mm).
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