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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?
Applicant Name (Manufacturer) :
RUSSELL B. WALTHER
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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