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510(k) Data Aggregation

    K Number
    K253545

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-10

    (88 days)

    Product Code
    Regulation Number
    888.3070
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vulcan Spinal System is intended for posterior, non-cervical, pedicle fixation 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, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

    When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vulcan Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Vulcan Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

    Refer to the Compatibility section of the VB Spine Vulcan Spinal System Instructions for Use for a listing of compatible systems.

    Device Description

    The Vulcan Spinal System is a top-loading, multiple component, non-cervical spinal fixation system implanted from the posterior approach and designed to provide fixation during the fusion process. The system is composed of polyaxial pedicle screws, locking set screws, and rods.

    AI/ML Overview

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