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

    CervAlign™ Anterior Cervical Plate System

    K Number: K183060 · Decision Jan 17, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    9
    Review Days
    76

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    Basic Information

    Device Name
    CervAlign™ Anterior Cervical Plate System
    K Number
    K183060
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
    Date Received
    November 2, 2018
    Decision Date
    January 17, 2019
    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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