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510(k) Data Aggregation

    K Number
    K242350
    Device Name
    Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
    Manufacturer
    Spinal Alignment Solutions, Inc.
    Date Cleared
    2024-10-28

    (81 days)

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

    Spinal Alignment Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is indicated for the use with Medtronic CD Horizon™ SOLERA™ Spinal System which is intended for posterior, lumbar and sacral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
    Device Description
    The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System consists of pre-bent spinal rods compatible for use with the Medtronic CD Horizon™ SOLERA™ Spinal System. The SAS PI Rod System is manufactured from either titanium alloy or cobalt chrome. The CD Horizon™ Spinal System consists of a variety of shapes and size of rods, screws, CROSSLINK® Plates, and connecting components which can be rigidly locked into avariety of configurations, with each construct being tailor-made for the individual case.
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