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

    HOLLYWOOD, PACIFICA, REDONDO, VENTURA

    K Number: K082310 · Decision Nov 10, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    422
    Registration Numbers
    422
    Same Product Code
    869
    Applicant Total
    25
    Review Days
    89

    Basic Information

    Device Name
    HOLLYWOOD, PACIFICA, REDONDO, VENTURA
    K Number
    K082310
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SEASPINE, INC.
    Date Received
    August 13, 2008
    Decision Date
    November 10, 2008
    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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