FDA.reportPublic FDA data

510(k) K230118

Device
Bony Trauma Extremity System (BTES) Screw Range, NX Nail
Applicant
Field Orthopaedics Pty, Ltd.
510(k) number
K230118
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-16
Date received
2023-01-17
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jillianne McKenzie
Address
30 Florence St. Teneriffe AU 4005 4005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K252901Tyber Medical Trauma ScrewTyber Medical, LLC2025-12-31
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K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.2025-10-02
K252019CurvaFix Low Profile SystemCurvafix, Inc.2025-08-29
K251382Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc.2025-08-27