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

    Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System

    K Number: K182007 · Decision Dec 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    7
    Review Days
    133

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    Basic Information

    Device Name
    Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
    K Number
    K182007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renovis Surgical Technologies
    Date Received
    July 27, 2018
    Decision Date
    December 7, 2018
    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

    K Number Device Name
    K190122 Renovis A200 PS Knee System as part of the Renovis A200 Knee System
    K181655 Renovis S180 Lateral Lumbar Interbody Fusion System
    K171543 Renovis Surgical Hip Replacement System
    K170888 Renovis S141 Lumbar Interbody Fusion System
    K153250 Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
    K143126 Renovis S141 Lumbar Interbody Cage System