FDA 510(k)

Bony Trauma Extremity System (BTES) Screw Range, NX Nail

K-Number: K230118 · 2023-02-16

Decision Date2023-02-16

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Bony Trauma Extremity System (BTES) Screw Range, NX Nail is a medical device manufactured by Field Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2023-02-16 under approval number K230118. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bony Trauma Extremity System (BTES) Screw Range, NX Nail?

Bony Trauma Extremity System (BTES) Screw Range, NX Nail is a medical device that received FDA 510(k) clearance on 2023-02-16. It is manufactured by Field Orthopaedics Pty, Ltd.. The 510(k) number is K230118.

When was Bony Trauma Extremity System (BTES) Screw Range, NX Nail approved by the FDA?

Bony Trauma Extremity System (BTES) Screw Range, NX Nail received FDA 510(k) clearance on 2023-02-16, under approval number K230118.

What company makes Bony Trauma Extremity System (BTES) Screw Range, NX Nail?

Bony Trauma Extremity System (BTES) Screw Range, NX Nail is manufactured by Field Orthopaedics Pty, Ltd..

What is the FDA product code for Bony Trauma Extremity System (BTES) Screw Range, NX Nail?

The FDA product code for Bony Trauma Extremity System (BTES) Screw Range, NX Nail is HWC. This falls under the Cardiovascular category.

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Other Devices by Field Orthopaedics Pty, Ltd.

K180348Field Orthopaedics Micro Screw System K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range

Related Devices (Code: HWC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.