BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    FaSet Fixation System

    K Number: K222515 · Decision Oct 5, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    77
    Applicant Total
    4
    Review Days
    47

    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
    FaSet Fixation System
    K Number
    K222515
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dio Medical Corporation
    Date Received
    August 19, 2022
    Decision Date
    October 5, 2022
    Product Code
    MRW
    Advisory Committee
    Unknown
    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
    MRW System, Facet Screw Spinal Device

    Similar 510(k) Clearances

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

    Ion-L

    FDA 510(k)
    FDA Unclassified ·Unknown

    CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)

    FDA 510(k)
    FDA Unclassified ·Unknown

    DiversiVy™ Facet Screw System

    FDA 510(k)
    FDA Unclassified ·Unknown

    Ion-C

    FDA 510(k)
    FDA Unclassified ·Unknown

    FFX Facet Fixation System

    FDA 510(k)
    FDA Unclassified ·Unknown

    CORUS-LX Implant

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Dio Medical Corporation

    K Number Device Name
    K222415 Rexious Spinal Fixation System
    K222572 FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System
    K222448 UNITY Sacroiliac Joint Fixation System