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

    SPICCA Stand-Alone Cervical Fusion Cages

    K Number: K230608 · Decision Aug 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    161
    Applicant Total
    6
    Review Days
    164

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    Basic Information

    Device Name
    SPICCA Stand-Alone Cervical Fusion Cages
    K Number
    K230608
    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
    March 3, 2023
    Decision Date
    August 14, 2023
    Product Code
    OVE
    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
    OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

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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
    K231145 Axis Anterior Cervical Plate System
    K221182 Southern Transforaminal Lumbar Interbody Fusion (TLIF)
    K221447 Southern Anterior Screw Fixated Cage (SASCA)