BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    SONIK MONARK 100

    K Number: K234036 · Decision Feb 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    56

    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
    SONIK MONARK 100
    K Number
    K234036
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuro Spinal Innovation, Inc.
    Date Received
    December 21, 2023
    Decision Date
    February 15, 2024
    Product Code
    LXM
    Advisory Committee
    Unknown
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LXM Manipulator, Plunger-Like Joint

    Similar 510(k) Clearances

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

    Spinalytics

    FDA 510(k)
    FDA Unclassified ·Unknown

    Atlas Percussion Adjusting Instrument

    FDA 510(k)
    FDA Unclassified ·Unknown

    VSTAAR AdjusteR

    FDA 510(k)
    FDA Unclassified ·Unknown

    KHAN KINETIC TREATMENT (KKT-M2)

    FDA 510(k)
    FDA Unclassified ·Unknown

    ACTIVATOR V-E

    FDA 510(k)
    FDA Unclassified ·Unknown

    MAX ADJUSTING INSTRUMENT

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all