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

    ART POSTERIOR SPINAL SYSTEM

    K Number: K033150 · Decision Mar 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    302
    Applicant Total
    8
    Review Days
    153

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    Basic Information

    Device Name
    ART POSTERIOR SPINAL SYSTEM
    K Number
    K033150
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Technologies AG
    Date Received
    September 30, 2003
    Decision Date
    March 1, 2004
    Product Code
    MNI
    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
    MNI Orthosis, Spinal Pedicle Fixation

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    Other Clearances by Advanced Medical Technologies AG

    K Number Device Name
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    K121332 LOOP CAGE
    K121330 WAVE O CAGE
    K121288 FUSE CAGE
    K100945 FUSE PLIF CAFE
    K080401 SHELL CAGE, WAVE CAGE, LOOP CAGE
    K033148 ART ANTERIOR SPINAL SYSTEM