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

    SIRION Lateral Lumbar Interbody System

    K Number: K192006 · Decision Apr 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    8
    Review Days
    248

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    Basic Information

    Device Name
    SIRION Lateral Lumbar Interbody System
    K Number
    K192006
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Astura Medical, LLC
    Date Received
    July 29, 2019
    Decision Date
    April 2, 2020
    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 Astura Medical, LLC

    K Number Device Name
    K202495 SIRION Lateral Lumbar Interbody Fusion
    K202065 DOLOMITE Anterior Cervical Stabilization System
    K192492 EL CAPITAN Anterior Lumber Interbody System
    K190426 ALTA Anterior Cervical Corpectomy System
    K182877 HALF DOME Posterior Lumbar Interbody System
    K182239 OLYMPIC Posterior Spinal Fixation System
    K181139 OLYMPIC Posterior Spinal Fixation System