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510(k) Data Aggregation

    K Number
    K092530
    Device Name
    SPRYTIE, MODELS ST001, ST002 AND ST003
    Manufacturer
    RUSSELL B. WALTHER
    Date Cleared
    2010-04-02

    (227 days)

    Product Code
    DZK
    Regulation Number
    872.4880
    Why did this record match?
    Product Code :

    DZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sprytie™ wires are indicated for use in the jaws in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together (maxillomandibular fixation).
    Device Description
    The Sprytie™ is a 25, 26, or 27 gauge annealed 316L stainless steel wire 7 inches in length, with a hollow 22TW, 23TW, or 24TW sieeve crimped over one end of the wire, respectively. The Sprytie™ is used in place of traditional light gauge stainless steel surgical wire during the placement of arch bars and splints, direct intraosseous wiring, bridal wire placement, and direct maxillomandibular fixation (ivy loops, risden wires, etc.). The sleeve end is inserted around the teeth first. The stiffness of the sleeve prevents the flexure of the wire.
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    K Number
    K022821
    Device Name
    ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E
    Manufacturer
    IDEATRICS, INC.
    Date Cleared
    2002-11-15

    (81 days)

    Product Code
    DZK
    Regulation Number
    872.4880
    Why did this record match?
    Product Code :

    DZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used in surgery for the application of wires to the jaws of adults and children. The device can be used to directly wire bony segments together, or for the application of arch bars to the teeth for stabilization of bony fragments or wiring the teeth together (maxillomandibular fixation).
    Device Description
    22, 24 and 26 gauge annealed 316LVM stainless steel wire in 5 ft. coils packaged in a thermoplastic cartridge that mounts on forceps
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