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

    ABBOTT SPINE, INC. SPINNAKER SYSTEM

    K Number: K052638 · Decision Nov 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    13
    Review Days
    42

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    Basic Information

    Device Name
    ABBOTT SPINE, INC. SPINNAKER SYSTEM
    K Number
    K052638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Spine, Inc.
    Date Received
    September 26, 2005
    Decision Date
    November 7, 2005
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNW Instrument, Biopsy

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    Other Clearances by Abbott Spine, Inc.

    K Number Device Name
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    K081622 UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
    K073202 ARDIS SPACER
    K072672 SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES
    K071174 PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS
    K062505 NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES
    K060634 NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES
    K060009 ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
    K052566 NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY
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