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

    WAVE O CAGE

    K Number: K121330 · Decision Jun 29, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    8
    Review Days
    57

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    Basic Information

    Device Name
    WAVE O CAGE
    K Number
    K121330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Technologies AG
    Date Received
    May 3, 2012
    Decision Date
    June 29, 2012
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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    Other Clearances by Advanced Medical Technologies AG

    K Number Device Name
    K121333 WAVE D CAGE
    K121332 LOOP CAGE
    K121288 FUSE CAGE
    K100945 FUSE PLIF CAFE
    K080401 SHELL CAGE, WAVE CAGE, LOOP CAGE
    K033148 ART ANTERIOR SPINAL SYSTEM
    K033150 ART POSTERIOR SPINAL SYSTEM