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

    Cure 2.0 Anterior Cervical Plate (ACP) System

    K Number: K210286 · Decision Mar 18, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    10
    Review Days
    44

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    Basic Information

    Device Name
    Cure 2.0 Anterior Cervical Plate (ACP) System
    K Number
    K210286
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meditech Spine, LLC
    Date Received
    February 2, 2021
    Decision Date
    March 18, 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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    Other Clearances by Meditech Spine, LLC

    K Number Device Name
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    K160604 Cure™ Anterior Cervical Plate (ACP) System
    K150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices
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