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

    POLYGRAFT BGS; BONE GRAFT SUBSTITUTE

    K Number: K040047 · Decision Dec 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    9
    Review Days
    340

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    Basic Information

    Device Name
    POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
    K Number
    K040047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteobiologics, Inc.
    Date Received
    January 12, 2004
    Decision Date
    December 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 Osteobiologics, Inc.

    K Number Device Name
    K051656 OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM
    K041382 POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
    K043172 TRUGRAFT BGS SYRINGE, MODEL 600-041
    K033707 POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX
    K032673 IMMIX PLASTIFILM
    K030288 POLYGRAFT BONE GRAFT SUBSTITUTE
    K024199 IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP
    K013429 ACTAEON PROBE