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

    APOLLO Anterior Cervical Plate (ACP) System

    K Number: K210325 · Decision Mar 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    7
    Review Days
    47

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    Basic Information

    Device Name
    APOLLO Anterior Cervical Plate (ACP) System
    K Number
    K210325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aurora Spine, Inc.
    Date Received
    February 4, 2021
    Decision Date
    March 23, 2021
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

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