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

    ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE

    K Number: K081979 · Decision Nov 6, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    234
    Same Product Code
    483
    Applicant Total
    8
    Review Days
    118

    Basic Information

    Device Name
    ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE
    K Number
    K081979
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    APATECH LTD.
    Date Received
    July 11, 2008
    Decision Date
    November 6, 2008
    Product Code
    MQV
    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
    MQV Filler, Bone Void, Calcium Compound

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    Other Clearances by APATECH LTD.

    K Number Device Name
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    K082575 ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES
    K082073 ACTIFUSE FLOW BONE GRAFT SUBSTITUTE
    K080736 ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE
    K071206 ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
    K040082 PORE-SI BONE GRAFT SUBSTITUTE
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