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

    RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM

    K Number: K142095 · Decision Oct 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    7
    Review Days
    75

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    Basic Information

    Device Name
    RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
    K Number
    K142095
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renovis Surgical Technologies, Inc.
    Date Received
    August 1, 2014
    Decision Date
    October 15, 2014
    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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    Other Clearances by Renovis Surgical Technologies, Inc.

    K Number Device Name
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    K141676 RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM
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