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510(k) Data Aggregation

    K Number
    K253169

    Validate with FDA (Live)

    Device Name
    Duet™ Spinal Fixation System
    Manufacturer
    Box Spine, LLC
    Date Cleared
    2026-02-23

    (150 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    18 - 120
    Reference & Predicate Devices
    K171838,K201427
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Duet™ spinal fixation construct is intended to provide immobilization and stabilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L1-S1: degenerative disk disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; pseudoarthrosis; and failed previous fusion.

    Device Description

    The Duet™ Spinal Fixation System is a spinal fixation device intended to immobilize and stabilize spinal segments as an adjunct to fusion in the lumbar and sacral regions of the spine. The Duet™ Spinal Fixation System is a dual screw system that eliminates the need for standard pedicle system rods. All components of the Duet™ Spinal Fixation System are manufactured from Ti-6Al-4V ELI.

    The Duet™ Spinal Fixation System construct of three components: halo-screw, sphere screw, and set screw. Both screws are offered in various lengths to accommodate individual patient anatomy. The Duet™ Spinal Fixation System is intended to be used at 1-level of the spinal segment to provide supplemental fixation.

    AI/ML Overview

    N/A

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