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

    EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE

    K Number: K040755 · Decision Jun 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    186
    Review Days
    85

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    Basic Information

    Device Name
    EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
    K Number
    K040755
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exactech, Inc.
    Date Received
    March 24, 2004
    Decision Date
    June 17, 2004
    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 Exactech, Inc.

    K Number Device Name
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