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510(k) Data Aggregation
K Number
K180932Device Name
Diamond Orthopedic Bone Fixation Screws and Pins
Manufacturer
Date Cleared
2018-05-09
(29 days)
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Diamond Orthopedic, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diamond Orthopedic Bone Fixation Screws and Pins are intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices.
Device Description
Diamond Orthopedic Bone Screws (cortical screws, cancellous screws, and headless compression screws) are available in thread diameters ranging from 1.5mm to 7.3mm, lengths ranging from 6mm to 180mm, and either solid or cannulated, and made of stainless steel or titanium.
Diamond Orthopedic External Fixation Screws are available in thread diameters ranging from 4mm to 6mm, lengths ranging from 60mm to 250mm, and thread lengths ranging from 18mm to 80mm, and made of stainless steel or titanium.
Diamond Orthopedic Kirschner Wires are available in wire diameters ranging from 1.0mm to 2.5mm, in lengths ranging from 100mm to 150mm, 0.7mm to 1.6mm, in lengths ranging from 101.6mm to 304.8mm and are partially or completely threaded, or smooth. Made of stainless steel or titanium.
Diamond Orthopedic Guide Wires are available in wire diameters ranging from 0.8mm to 2.8mm, in lengths ranging from 100mm to 450mm, are partially threaded or smooth. Made of stainless steel, titanium, or cobalt.
Diamond Orthopedic Steinmann Pins are available in wire diameters ranging from 2mm to 4.7mm, in lengths ranging from 228.6mm to 304.8mm, are completely threaded, or smooth. Made of stainless steel or titanium.
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