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

    Renovis Anterior Cervical Plate System

    K Number: K152193 · Decision Sep 25, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    7
    Review Days
    51

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    Basic Information

    Device Name
    Renovis Anterior Cervical Plate System
    K Number
    K152193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renovis Surgical Technologies, Inc.
    Date Received
    August 5, 2015
    Decision Date
    September 25, 2015
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

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    Other Clearances by Renovis Surgical Technologies, Inc.

    K Number Device Name
    K180502 S128 Anterior Lumbar Interbody Fusion (ALIF) System
    K143647 Renovis Surgical Hip Replacement System
    K141676 RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM
    K142095 RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
    K141370 RENOVIS CEMENTED HIP SYSTEM
    K140106 S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM