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

    CUTTING EDGE SPINE INTERBODY FUSION DEVICE

    K Number: K102957 · Decision Apr 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    11
    Review Days
    205

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    Basic Information

    Device Name
    CUTTING EDGE SPINE INTERBODY FUSION DEVICE
    K Number
    K102957
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cutting Edge Spine, LLC
    Date Received
    October 5, 2010
    Decision Date
    April 28, 2011
    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 Cutting Edge Spine, LLC

    K Number Device Name
    K250605 EVOL® ha – Hyper C Cervical Interbody Fusion System
    K230689 T-FIX™ 3DSI Joint Fusion System
    K214123 T-FIX® 3DSI Joint Fusion System
    K200991 EVOL Spinal Interbody System
    K200552 EVOS Lumbar Interbody System
    K192497 EVOL ha - D Lateral Interbody Fusion System
    K190025 EVOL® -SI Joint Fusion System
    K180674 EVOL® ha-C Cervical Interbody Fusion System
    K180891 EVOL Spinal Interbody System, EVOS Lumbar Interbody System
    K150321 EVOS Lumbar Interbody System
    Search all 11 clearances from Cutting Edge Spine, LLC →