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

    Cure™ Lumbar Plate System

    K Number: K201136 · Decision May 12, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    10
    Review Days
    14

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    Basic Information

    Device Name
    Cure™ Lumbar Plate System
    K Number
    K201136
    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
    April 28, 2020
    Decision Date
    May 12, 2020
    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
    K210286 Cure 2.0 Anterior Cervical Plate (ACP) System
    K201506 Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
    K181543 Cure™ OPEL-C Plate System
    K180090 Cure™ Lumbar Plate System
    K171538 Cure™ Lumbar Plate System
    K170395 Talos® Lumbar (HA) PEEK IBF Devices
    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
    K142345 Talos-C(HA) Cervical Intervertebral Body Fusion Devices