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

    Align Lumbar Interbody Fusion System

    K Number: K221535 · Decision Jul 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    8
    Review Days
    56

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    Basic Information

    Device Name
    Align Lumbar Interbody Fusion System
    K Number
    K221535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acuity Surgical Devices, LLC
    Date Received
    May 27, 2022
    Decision Date
    July 22, 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 Acuity Surgical Devices, LLC

    K Number Device Name
    K251735 Stabilis SA Cervical Stand-Alone System (Various PNs)
    K251335 Tera Lumbar Interbody Fusion System (Various PNs)
    K243386 Ventris Intervertebral Body Fusion Device
    K241413 sagAlign Lumbar Cage System (Various PNs)
    K230639 Align Cervical Interbody Fusion System
    K222561 Align
    K201671 A-Link Z