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

    ARDIS INTERBODY SYSTEM

    K Number: K133184 · Decision Jan 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    38
    Review Days
    105

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    Basic Information

    Device Name
    ARDIS INTERBODY SYSTEM
    K Number
    K133184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Spine, Inc.
    Date Received
    October 17, 2013
    Decision Date
    January 30, 2014
    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 Zimmer Spine, Inc.

    K Number Device Name
    K153631 Zimmer Virage OCT Spinal Fixation System
    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
    K141500 OPTIO-C ANTERIOR CERVICAL SYSTEM
    K133556 VIRAGE OCT SPINAL FIXATION SYSTEM
    K140611 TRINICA ANTERIOR LUMBAR PLATE SYSTEM
    Search all 38 clearances from Zimmer Spine, Inc. →