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510(k) Data Aggregation
K Number
K092530Device Name
SPRYTIE, MODELS ST001, ST002 AND ST003
Manufacturer
RUSSELL B. WALTHER
Date Cleared
2010-04-02
(227 days)
Product Code
DZK
Regulation Number
872.4880Why 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
K022821Device 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
872.4880Why 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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