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FDA 510(k)

Field Orthopaedics Micro Screw System

K-Number: K180348 · 2018-07-17

ApplicantField Orthopaedics Pty, Ltd.
Decision Date2018-07-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Field Orthopaedics Micro Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Field Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2018-07-17 under 510(k) 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. The listed applicant is Field Orthopaedics Pty, Ltd.. The 510(k) number is K180348.

When did Field Orthopaedics Micro Screw System receive FDA 510(k) clearance?

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

Who is the listed applicant for Field Orthopaedics Micro Screw System?

The FDA 510(k) record lists Field Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Field Orthopaedics Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailK200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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.

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