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

    Talos® Lumbar (HA) PEEK IBF Devices

    K Number: K170395 · Decision Jun 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    10
    Review Days
    114

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    Basic Information

    Device Name
    Talos® Lumbar (HA) PEEK IBF Devices
    K Number
    K170395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meditech Spine, LLC
    Date Received
    February 8, 2017
    Decision Date
    June 2, 2017
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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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
    K201136 Cure™ Lumbar Plate System
    K181543 Cure™ OPEL-C Plate System
    K180090 Cure™ Lumbar Plate System
    K171538 Cure™ Lumbar Plate System
    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