BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Companion Spine DIAM™ Instrumentation

    K Number: K253118 · Decision Dec 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    83

    Basic Information

    Device Name
    Companion Spine DIAM™ Instrumentation
    K Number
    K253118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.4520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Companion Spine France
    Date Received
    September 24, 2025
    Decision Date
    December 16, 2025
    Product Code
    QLR
    Advisory Committee
    Orthopedic
    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
    QLR Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices