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

    EXPEDIUM MIS SPINE SYSTEM

    K Number: K041801 · Decision Sep 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    68
    Review Days
    68

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    Basic Information

    Device Name
    EXPEDIUM MIS SPINE SYSTEM
    K Number
    K041801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Spine, Inc.
    Date Received
    July 2, 2004
    Decision Date
    September 8, 2004
    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 Depuy Spine, Inc.

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    K110353 MOUNTAINEER OCT SPINAL SYSTEM
    K110216 EXPEDIUM SYSTEM, VIPER SYSTEM
    K103133 VEPER SYSTEM, EXPEDIUM SYSTEM
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