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510(k) Data Aggregation

    K Number
    K973560
    Device Name
    BONE GRAFT HARVESTER
    Manufacturer
    DS MFG., INC.
    Date Cleared
    1997-11-12

    (54 days)

    Product Code
    HWE
    Regulation Number
    878.4820
    Why did this record match?
    Applicant Name (Manufacturer) :

    DS MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended to be used to obtain bone from the iliac crest or other skeletal sites. It is indicated in conditions requiring the examination of bone, e.g., metabolic bone disease, metastatic disease to the bone, osteoporosis, and osteomalacia, or in conditions requiring the use of bone graft, e.g., nonunion or delayed union of fractures, bone defects, and fusions.
    Device Description
    Bone Graft Harvester
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