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510(k) Data Aggregation

    K Number
    K252873

    Validate with FDA (Live)

    Device Name
    Q Interbody Instruments
    Manufacturer
    K2m,Inc.
    Date Cleared
    2026-02-06

    (149 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K240662
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VB Spine Q Interbody Instruments are intended to be used as accessories to Stryker's Spine Guidance System to facilitate placement of VB Spine implants. They can be navigated instruments or non-navigated manual instruments. When navigated, VB Spine Q Interbody Instruments are specifically designed for use with Stryker's Spine Guidance Software. They are intended to be used with associated trackers and adaptors to facilitate preparation and placement of VB Spine interbody implants in accordance with the indications and contraindications of the associated VB Spine Implant System and/or Stryker's Spine Guidance System.

    Device Description

    The Q Interbody Instruments include Q Inserters and Q Interbody Trials, as well as new system components including Q Calibration Devices. The Q Interbody Instruments are intended to be used to facilitate preparation and placement of VB Spine interbody implants.

    These instruments are designed to be compatible with Stryker's Spine Guidance 5.3 Software.

    AI/ML Overview

    N/A

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