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

    Normandy VBR System

    K Number: K180673 · Decision Jul 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    17
    Applicant Total
    30
    Review Days
    121

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    Basic Information

    Device Name
    Normandy VBR System
    K Number
    K180673
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zavation Medical Products, LLC
    Date Received
    March 14, 2018
    Decision Date
    July 13, 2018
    Product Code
    PLR
    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
    PLR Spinal Vertebral Body Replacement Device - Cervical

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