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

    Southern Transforaminal Lumbar Interbody Fusion (TLIF)

    K Number: K221182 · Decision Dec 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    6
    Review Days
    227

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    Basic Information

    Device Name
    Southern Transforaminal Lumbar Interbody Fusion (TLIF)
    K Number
    K221182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Southern Medical (Pty) , Ltd.
    Date Received
    April 25, 2022
    Decision Date
    December 8, 2022
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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    Other Clearances by Southern Medical (Pty) , Ltd.

    K Number Device Name
    K253373 Southern Craniomaxillofacial (CMF) System
    K230607 SPICCA Cervical Fusion Cages
    K230608 SPICCA Stand-Alone Cervical Fusion Cages
    K231145 Axis Anterior Cervical Plate System
    K221447 Southern Anterior Screw Fixated Cage (SASCA)