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510(k) Data Aggregation

    K Number
    K253432

    Validate with FDA (Live)

    Device Name
    DiversiVy™ Facet Screw System
    Manufacturer
    Vy Spine, LLC
    Date Cleared
    2026-03-19

    (169 days)

    Product Code
    MRW
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K130863
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DiversiVy™ Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment with or without bone graft, at single or multiple levels from L1 to S1 (inclusive), for any or all of the following: Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous fusions which are symptomatic, Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

    Device Description

    The DiversiVy™ Facet Screw System is comprised of implants components. The implant component, the DiversiVy™ Facet Screw, is an assortment of screws, which insert through the facets of two adjacent spinal vertebral bodies. The DiversiVy™ Facet Screw is made from Titanium Alloy conforming to ASTM F-136.

    AI/ML Overview

    N/A

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