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

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

    K Number: K082575 · Decision Nov 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    8
    Review Days
    81

    Basic Information

    Device Name
    ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES
    K Number
    K082575
    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
    September 5, 2008
    Decision Date
    November 25, 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
    K090850 ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
    K081979 ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE
    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
    K033722 APAPORE BONE GRAFT SUBSTITUTE