BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Spinous Process Spacer/Plate

    PMA: P240043 · Supplement: S001 · Decision Apr 1, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Prosthesis, Spinous Process Spacer/Plate
    Trade Name
    DIAM­™ Spinal Stabilization System
    PMA Number
    P240043
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    NQO
    Generic Name
    Prosthesis, spinous process spacer/plate
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 1, 2026
    Date Received
    January 29, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a shelf-life extension from 1-year to 5-years for the DIAM™ Spinal Stabilization System. Based upon the information submitted, the PMA supplement is approved.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NQO Prosthesis, Spinous Process Spacer/Plate