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

    REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1

    K Number: K082419 · Decision May 27, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    5
    Review Days
    278

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    Basic Information

    Device Name
    REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1
    K Number
    K082419
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intra-Lock International, Inc.
    Date Received
    August 22, 2008
    Decision Date
    May 27, 2009
    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 Intra-Lock International, Inc.

    K Number Device Name
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