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510(k) Data Aggregation

    K Number
    K010847
    Device Name
    K'FIX
    Manufacturer
    AVANTA ORTHOPAEDICS, INC.
    Date Cleared
    2001-06-19

    (90 days)

    Product Code
    NDL
    Regulation Number
    888.3040
    Why did this record match?
    Product Code :

    NDL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010545
    Device Name
    TBW
    Manufacturer
    TRI-MED, INC.
    Date Cleared
    2001-06-06

    (103 days)

    Product Code
    NDL, LRN
    Regulation Number
    888.3040
    Why did this record match?
    Product Code :

    NDL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, of application malleolus, distal ulna, distal ulna, distal humerus, and proximal humerus. The decision to use a specific implant as well as the size and shape of the implant used I he uccision to use a specific xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx the circumstances and configuration of the injury.
    Device Description
    The TriMed tension band sleds are double 'U' shaped wire implants that are used as an aid to fracture fixation. They are manufactured from either medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy and vary in diameter from .028" to .250".
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