LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250599

    Validate with FDA (Live)

    Device Name
    ExcelsiusGPS™ Instruments
    Manufacturer
    Globus Medical, Inc.
    Date Cleared
    2025-11-05

    (250 days)

    Product Code
    OLO,MAX,ODP,OVD
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K191100,K211616,K222270,K201692,K203714,K200953,K172341,K193541,K161379,K203278
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ExcelsiusGPS™
    ExcelsiusGPS™ is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

    ExcelsiusHub™
    ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

    Device Description

    Subject ExcelsiusGPS™ instruments consist of verification adapters and surgical instruments, including interbody inserters and trials, that may be used manually or navigated with the use of ExcelsiusGPS™ or ExcelsiusHub™. The surgical instruments are used to prepare the implant site or implant the device. Instruments are non-sterile and reusable.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1