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510(k) Data Aggregation

    K Number
    K252560

    Validate with FDA (Live)

    Device Name
    Atlas Spine HiRISE™ Expandable Cervical Corpectomy System
    Manufacturer
    Atlas Spine, Inc.
    Date Cleared
    2025-11-10

    (89 days)

    Product Code
    PLR
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Atlas Spine HiRISE™ Expandable Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1). The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion.

    When used in the cervical spine (C2-T1), Atlas Spine HiRISE™ Expandable Cervical Corpectomy System spacers are intended for use 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 the cervical degenerative disorders. These spacers are 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. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine.

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    AI/ML Overview

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