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

    ART ANTERIOR SPINAL SYSTEM

    K Number: K033148 · Decision Apr 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    8
    Review Days
    195

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    Basic Information

    Device Name
    ART ANTERIOR SPINAL SYSTEM
    K Number
    K033148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Technologies AG
    Date Received
    September 30, 2003
    Decision Date
    April 12, 2004
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

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    Other Clearances by Advanced Medical Technologies AG

    K Number Device Name
    K121333 WAVE D CAGE
    K121332 LOOP CAGE
    K121330 WAVE O CAGE
    K121288 FUSE CAGE
    K100945 FUSE PLIF CAFE
    K080401 SHELL CAGE, WAVE CAGE, LOOP CAGE
    K033150 ART POSTERIOR SPINAL SYSTEM