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FDA 510(k)

ARTFX Trauma Bone Plate and Screw System

K-Number: K242939 · 2024-12-23

ApplicantArtfx Medical
Decision Date2024-12-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTFX Trauma Bone Plate and Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Artfx Medical. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K242939. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTFX Trauma Bone Plate and Screw System?

ARTFX Trauma Bone Plate and Screw System is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Artfx Medical. The 510(k) number is K242939.

When did ARTFX Trauma Bone Plate and Screw System receive FDA 510(k) clearance?

ARTFX Trauma Bone Plate and Screw System received FDA 510(k) clearance on 2024-12-23, under 510(k) number K242939.

Who is the listed applicant for ARTFX Trauma Bone Plate and Screw System?

The FDA 510(k) record lists Artfx Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTFX Trauma Bone Plate and Screw System?

The FDA product code for ARTFX Trauma Bone Plate and Screw System is HRS.

Other records listing Artfx Medical 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.

K240889ARTFX Lumbar PEEK CagesK240893ARTFX MEDICAL Cervical PEEK CagesK212220ArtFX Spinal Fixation SystemK211718Venus Cervical Plate System

Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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