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

    MODIFICATION TO: S4 SPINAL SYSTEM

    K Number: K090657 · Decision Apr 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    413
    Registration Numbers
    413
    Same Product Code
    873
    Applicant Total
    7
    Review Days
    39

    Basic Information

    Device Name
    MODIFICATION TO: S4 SPINAL SYSTEM
    K Number
    K090657
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AESCULAP IMPLANT SYSTEMS
    Date Received
    March 12, 2009
    Decision Date
    April 20, 2009
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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