Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253158

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-01-07

    (103 days)

    Product Code
    Regulation Number
    888.3060
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K231836, K233807

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VyBrate-L™ VBR System is intended for use in the thoracolumbar spine (T1‐L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VyBrate-L™ VBR device is intended for use with autograft and/or allograft bone graft material and must be used with supplemental fixation systems.

    The VyBrate-C™ VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The VyBrate-C™ VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.

    These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VyBrate-C™ VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

    Device Description

    The Vy Spine™ VyBrate™ VBR System is comprised of implants components. The implant component, the VyBrate™ VBR device, is a spacer, which inserts between vertebral bodies in the anterior column of the thoracolumbar or cervical spine. The spacer is made of OXPEKK with Tantalum markers.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1