BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Axis Spine Technologies ALIF

    K Number: K200352 · Decision May 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    254
    Registration Numbers
    254
    Same Product Code
    194
    Applicant Total
    2
    Review Days
    97

    Basic Information

    Device Name
    Axis Spine Technologies ALIF
    K Number
    K200352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axis Spine Technologies Ltd
    Date Received
    February 13, 2020
    Decision Date
    May 20, 2020
    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 Axis Spine Technologies Ltd

    K Number Device Name
    K210590 Axis Spine Technologies ALIF