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510(k) Data Aggregation

    K Number
    K081790
    Device Name
    MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM
    Date Cleared
    2008-07-24

    (29 days)

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

    TRINITY ORTHOPEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Trinity SPMA Pedicle Screw System 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
    Device Description
    The Single Planar Multi Axial (SPMA) Pedicle Screw System is an internal fixation device for spinal surgery consisting of rods and pedicle screw assemblies. The axle that connects the screw to the saddle allows the saddle to be adjusted in a single plane to any angle, up to 60° from the midline.
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    K Number
    K070295
    Device Name
    SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
    Date Cleared
    2007-05-21

    (110 days)

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

    TRINITY ORTHOPEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Single Planar Multi Axial (SPMA) Pedicle Screw System 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal turnor, pseudoarthrosis, and failed previous fusion.
    Device Description
    The SPMA Pedicle Screw System is an internal fixation device for spinal surgery consisting of rods and pedicle screw assemblies (screw, saddle, axle, locking washer and set screw). The axle that connects the screw to the saddle allows the saddle to be adjusted in a single plane to any angle, up to 60 ° from the midline. Grooves in the head of the screw and in the inferior face of the locking washer interdigitate with the splined surface of the rod to allow the assembly to be rigidly fixed in place when tightened.
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