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510(k) Data Aggregation
K Number
K060654Device Name
DSI PINS AND WIRES
Manufacturer
DELTA SURGICAL INSTRUMENTS, INC.
Date Cleared
2006-04-28
(46 days)
Product Code
HTY, JDW
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
DELTA SURGICAL INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DSI Pins and Wires are non-sterile, single-use pins and wires intended to be used for the fixation of bone fractures, bone reconstruction, or as a guide/aid for the insertion of other medical devices.
Device Description
DSI Pins and Wires consist of various pins and wires for use in the fixation of bone fractures, bone reconstruction, or as a guide/aid for insertion of other medical devices. All DSI Pins and Wires included in this submission are manufactured of implant grade stainless steel. All DSI Pins and Wires included in this submission will be marketed non-sterile. Kirschner Wires, Steinmann Pins and Cerclage Wires are included in this submission.
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