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

    OPTIO-C ANTERIOR CERVICAL SYSTEM

    K Number: K141500 · Decision Sep 23, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    38
    Review Days
    109

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    Basic Information

    Device Name
    OPTIO-C ANTERIOR CERVICAL SYSTEM
    K Number
    K141500
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Spine, Inc.
    Date Received
    June 6, 2014
    Decision Date
    September 23, 2014
    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 Zimmer Spine, Inc.

    K Number Device Name
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    K150896 Vitality Spinal Fixation System
    K151031 Virage OCT Spinal Fixation System
    K142752 Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
    K143626 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System
    K143297 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)
    K142053 UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
    K133556 VIRAGE OCT SPINAL FIXATION SYSTEM
    K140611 TRINICA ANTERIOR LUMBAR PLATE SYSTEM
    K133184 ARDIS INTERBODY SYSTEM
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