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

    Opticage(R) Expandable Interbody Fusion Device

    K Number: K160464 · Decision Apr 4, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    8
    Review Days
    45

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    Basic Information

    Device Name
    Opticage(R) Expandable Interbody Fusion Device
    K Number
    K160464
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interventional Spine, Inc.
    Date Received
    February 19, 2016
    Decision Date
    April 4, 2016
    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 Interventional Spine, Inc.

    K Number Device Name
    K152156 Opticage Expandable Interbody Fusion Device
    K140716 OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE
    K133583 OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070
    K132479 OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00
    K113527 OPTICAGE INTERBODY FUSION DEVICE
    K090767 PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER
    K082795 SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT