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510(k) Data Aggregation
K Number
K180348Device Name
Field Orthopaedics Micro Screw System
Manufacturer
Field Orthopaedics Pty. Ltd.
Date Cleared
2018-07-17
(159 days)
Product Code
HWC, HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Field Orthopaedics Pty. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Field Orthopaedics Micro Screw System consists of the following kits with the following indications:
The FO Micro Screw Kit is intended for fixation of fractures, osteotomies, and arthrodeses of small bones in the foot, hand, and forearm.
The FO Pin and Wire Kit is intended for fixation of bone fractures or as guidance at insertion of implants into the skeletal system.
Device Description
The Field Orthopaedics Micro Screw System is an extremity trauma system consisting of the FO Micro Screw Kit and the FO Pin and K-Wire Kit.
The FO Micro Screw Kit includes 1.5 mm and 2.0 mm diameter cannulated compression screws with lengths ranging from 6 mm to 16 mm increments and 0.6 mm single trocar K-wires of length 70 mm. Accompanying the screws is a specifically designed instrument kit, tailored to the insertion of the 1.5 and 2.0 FO Micro Screw.
The FO Pin and K-Wire Kit includes 0.6, 0.8, 1.0 and 1.2 mm double trocar K-wires of length options 70 mm and 150 mm; and 1.6 and 2.0 mm double trocar Pins of length 150 mm. Accompanying the FO Pins and K-Wires are appropriately sized guide sleeves to aid insertion.
Materials: All Field Orthopaedics Micro Screws are made from Titanium Alloy (ASTM F136).
All Field Orthopaedics Pins and K-Wires are made from Stainless Steel Alloy (ASTM F138).
The instrumentation is made from medical grades stainless steel, anodized aluminium, and marked with epoxy resin.
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