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

    OPTIUM DBM GEL AND PUTTY

    K Number: K053098 · Decision Nov 28, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    30
    Applicant Total
    1
    Review Days
    25

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    Basic Information

    Device Name
    OPTIUM DBM GEL AND PUTTY
    K Number
    K053098
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifenet
    Date Received
    November 3, 2005
    Decision Date
    November 28, 2005
    Product Code
    MBP
    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
    MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

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