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

    S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM

    K Number: K131122 · Decision Sep 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    9
    Review Days
    149

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    Basic Information

    Device Name
    S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
    K Number
    K131122
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renovis Surgical Technologies, LLC
    Date Received
    April 22, 2013
    Decision Date
    September 18, 2013
    Product Code
    OVD
    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
    OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

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