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

    SpineView X-Pac Expandable Lumbar Cage System

    K Number: K160856 · Decision Aug 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    9
    Review Days
    126

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    Basic Information

    Device Name
    SpineView X-Pac Expandable Lumbar Cage System
    K Number
    K160856
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spine View, Inc.
    Date Received
    March 28, 2016
    Decision Date
    August 1, 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 Spine View, Inc.

    K Number Device Name
    K152539 SpineView X-Pac Expandable Lumbar Cage System
    K122134 FLEXLITE CAMERA
    K121548 SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
    K120680 ENSPIRE DISCECTOMY SYSTEM
    K113362 SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
    K110992 ENSPIRE DEBRIDER SYSTEM
    K090278 ENSPIRE DEBRIDER SYSTEM
    K081051 SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE