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

    Omnia Medical Rotary PLIF System

    K Number: K183659 · Decision Feb 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    11
    Review Days
    41

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    Basic Information

    Device Name
    Omnia Medical Rotary PLIF System
    K Number
    K183659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omnia Medical, LLC
    Date Received
    December 27, 2018
    Decision Date
    February 6, 2019
    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 Omnia Medical, LLC

    K Number Device Name
    K242431 Omnia Medical PsiF DNA™ System
    K240623 Omnia Medical TiBrid™-SA System
    K230424 Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System
    K223321 Omnia Medical Coupler-C Anterior Cervical Plate
    K212612 Omnia Medical TiBrid-SC
    K203207 Omnia Medical TiBrid-SA
    K192096 Omnia Medical Trauma Screws
    K190363 Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage
    K191778 Omnia Medical VBR
    K172323 Omnia Medical VBR
    Search all 11 clearances from Omnia Medical, LLC →