BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    3D MAC Titanium Cranial Plate (TCP) System

    K Number: K253116 · Decision Jun 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    267

    Basic Information

    Device Name
    3D MAC Titanium Cranial Plate (TCP) System
    K Number
    K253116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Surgeon General, Department of the Army (TSG-DA)
    Date Received
    September 24, 2025
    Decision Date
    June 18, 2026
    Product Code
    GXN
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXN Plate, Cranioplasty, Preformed, Non-Alterable

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