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510(k) Data Aggregation

    K Number
    K253373

    Validate with FDA (Live)

    Device Name
    Southern Craniomaxillofacial (CMF) System
    Manufacturer
    Southern Medical (Pty) , Ltd.
    Date Cleared
    2025-12-19

    (80 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K160363,K953385,K140037
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Southern MF System is a maxillofacial plate and screw system intended for osteotomy, reconstruction, and fracture fixation in midface, maxillofacial, and mandibular surgeries.

    Device Description

    The Southern MF System includes a series of plates, meshes, and screws intended to stabilize and immobilize bone segments in the maxillofacial, midface, and mandibular regions, thereby facilitating osseous fusion in a set orientation. The Southern MF System consists of bone plates made from Grade 2 commercially pure titanium (ASTM F67) in various shapes and sizes to accommodate various surgical requirements. It also includes bone screws made from Ti-6Al-4V ELI (ASTM F136) Titanium Alloy. The bone screws are made available in a variety of lengths and diameters, and in self-drilling and self-tapping variations. The Subject Device is not intended for use in the orbital roof and can only be used if no exposure of the intracranial compartment is presented.

    AI/ML Overview

    N/A

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