FDA 510(k)

Field Orthopaedics Micro Screw System

K-Number: K180348 · 2018-07-17

Decision Date2018-07-17

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Field Orthopaedics Micro Screw System is a medical device manufactured by Field Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2018-07-17 under approval number K180348. 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 Field Orthopaedics Micro Screw System?

Field Orthopaedics Micro Screw System is a medical device that received FDA 510(k) clearance on 2018-07-17. It is manufactured by Field Orthopaedics Pty, Ltd.. The 510(k) number is K180348.

When was Field Orthopaedics Micro Screw System approved by the FDA?

Field Orthopaedics Micro Screw System received FDA 510(k) clearance on 2018-07-17, under approval number K180348.

What company makes Field Orthopaedics Micro Screw System?

Field Orthopaedics Micro Screw System is manufactured by Field Orthopaedics Pty, Ltd..

What is the FDA product code for Field Orthopaedics Micro Screw System?

The FDA product code for Field Orthopaedics Micro Screw System is HWC. This falls under the Cardiovascular category.

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Other Devices by Field Orthopaedics Pty, Ltd.

K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range K230118Bony Trauma Extremity System (BTES) Screw Range, NX Nail

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.