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

    AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM

    K Number: K100623 · Decision Jun 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    7
    Review Days
    97

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    Basic Information

    Device Name
    AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
    K Number
    K100623
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap Implant Systems
    Date Received
    March 4, 2010
    Decision Date
    June 9, 2010
    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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    Other Clearances by Aesculap Implant Systems

    K Number Device Name
    K140452 VEGA KNEE SYSTEM
    K121879 VEGA KNEE SYSTEM
    K101815 ENDURO KNEE SYSTEM
    K090299 BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS
    K090657 MODIFICATION TO: S4 SPINAL SYSTEM
    K071945 S4 SPINAL SYSTEM