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

    Align

    K Number: K222561 · Decision Sep 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    8
    Review Days
    30

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    Basic Information

    Device Name
    Align
    K Number
    K222561
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acuity Surgical Devices, LLC
    Date Received
    August 24, 2022
    Decision Date
    September 23, 2022
    Product Code
    OVD
    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
    OVD Intervertebral Fusion Device With Integrated Fixation, 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
    K221535 Align Lumbar Interbody Fusion System
    K201671 A-Link Z