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510(k) Data Aggregation
K Number
K100736Device Name
KIRSCHNER AND GUIDE WIRES
Manufacturer
SMT SCHILLING METALLTECHNIK GMBH
Date Cleared
2010-09-10
(179 days)
Product Code
HTY, JDW
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
SMT SCHILLING METALLTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthopaedic fixation pins and wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.
Device Description
Orthopaedic fixation pins and wires are metal pins for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implantation through the skin so that traction may be applied to the skeleton system. To ensure the multi-use of these devices, many different models are available. The differences can be as follows: Diameter: from 0.6 up to 6.35mm (0.020 up to 0.250 inch) Length: from 60 up to 500 mm (2.36 up to 19.69 inch) Tips: diamond or trocar Point, round, flat, with or without 3- or 4- shank ends, with or without spherical shape. Surface: complete or partial smooth and / or threaded, with or without threading cutter.
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