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510(k) Data Aggregation

    K Number
    K252432

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-25

    (236 days)

    Product Code
    Regulation Number
    888.3080
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SpinePoint Flex-Z™ Cervical Cage is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies) at multiple contiguous levels from C2-T1 spine using an anterior approach. The SpinePoint Flex-Z™ Cervical Cage is intended to be used with supplemental fixation systems and with allograft/allogenic bone graft, comprised of cancellous, cortical, and corticocancellous bone to facilitate fusion. Patients should receive 6 weeks of non-operative treatment prior to treatment with the SpinePoint Flex-Z™ Cervical Cage.

    Device Description

    The SpinePoint Flex-Z™ Cervical Cage is an intervertebral body fusion device additively manufactured Grade 23 titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The device consists of lattice and a z-shaped frame to improve the stability of the spine while supporting fusion. Additional features include a graft window for packing bone graft and porous endplates to ensure placement is maintained after insertion and aid in osseointegration.

    The Flex-Z™ Cervical Cage is available in multiple footprints, heights, and degrees of lordosis to accommodate patient anatomies and surgical approach. Implants are provided sterile in sterile packaging, are single-use only, and are intended to be used with FDA-cleared fixation devices such as an anterior cervical plate system.

    AI/ML Overview

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