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510(k) Data Aggregation

    K Number
    K260546

    Validate with FDA (Live)

    Device Name
    Q Pedicle Instruments
    Manufacturer
    K2m, Inc.
    Date Cleared
    2026-03-17

    (27 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Special
    Panel
    Orthopedic
    Age Range
    12 - 120
    Reference & Predicate Devices
    K241517,K240662
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VB Spine Q Pedicle 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 Pedicle Instruments are specifically designed for use with the Spine Guidance Software. They are intended to be used with a Q Navigation Adaptor and associated trackers manually or under power with a Stryker Rotary Handpiece to facilitate pedicle preparation and placement of VB Spine implants in the non-cervical spine in adult and pediatric (adolescent) patients 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 Pedicle Instruments include Q Taps and Q Screwdrivers. The Q Pedicle Instruments are intended to be used to facilitate pedicle preparation and screw placement of VB Spine implants.

    These instruments are designed to be compatible with Stryker's Spine Guidance 5 Software and Mako Spine System.

    AI/ML Overview

    N/A

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