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

    POLYGRAFT BGS; BONE GRAFT SUBSTITUTE

    K Number: K041382 · Decision Jun 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    53
    Applicant Total
    9
    Review Days
    388

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    Basic Information

    Device Name
    POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
    K Number
    K041382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Osteobiologics, Inc.
    Date Received
    May 25, 2004
    Decision Date
    June 17, 2005
    Product Code
    JDK
    Advisory Committee
    General, Plastic Surgery
    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
    JDK Prosthesis, Hip, Cement Restrictor

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    Other Clearances by Osteobiologics, Inc.

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    K040047 POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
    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