BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇿🇦 South Africa

    Southern Craniomaxillofacial (CMF) System

    K Number: K253373 · Decision Dec 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    6
    Review Days
    80

    Basic Information

    Device Name
    Southern Craniomaxillofacial (CMF) System
    K Number
    K253373
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Southern Medical (Pty) , Ltd.
    Date Received
    September 30, 2025
    Decision Date
    December 19, 2025
    Product Code
    JEY
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JEY Plate, Bone

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