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

    CALTRIX RESORBABLE BONE VOID FILLER

    K Number: K083279 · Decision Jan 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    4
    Review Days
    82

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    Basic Information

    Device Name
    CALTRIX RESORBABLE BONE VOID FILLER
    K Number
    K083279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ag Digital Technology Corp.
    Date Received
    November 7, 2008
    Decision Date
    January 28, 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 Ag Digital Technology Corp.

    K Number Device Name
    K121453 A-GRIX TE RESORABLE BONE VOID FILLER
    K101641 AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
    K091688 A-GRIX RESORBABLE BONE VOID FILLER