BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    ARVIS® Shoulder

    K Number: K243950 · Decision Jan 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    21

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ARVIS® Shoulder
    K Number
    K243950
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kico Knee Innovation Company Pty, Ltd.
    Date Received
    December 23, 2024
    Decision Date
    January 13, 2025
    Product Code
    SBF
    Advisory Committee
    Neurology
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SBF Orthopedic Augmented Reality

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (SBF), ordered by most recent decision date.

    Knee+

    FDA 510(k)
    FDA Class 2 ·Neurology

    NextAR Hip Platform

    FDA 510(k)
    FDA Class 2 ·Neurology

    xvision Spine system

    FDA 510(k)
    FDA Class 2 ·Neurology

    SpineAR SNAP (SyncAR Spine)

    FDA 510(k)
    FDA Class 2 ·Neurology

    OptiVu™ Shoulder

    FDA 510(k)
    FDA Class 2 ·Neurology

    NextAR(TM) Shoulder Platform

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Kico Knee Innovation Company Pty, Ltd.

    K Number Device Name
    K242009 360CAS Knee