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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 a medical device manufactured by Artfx Medical. It received FDA 510(k) clearance on 2024-12-23 under approval 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. It is manufactured by Artfx Medical. The 510(k) number is K242939.

When was ARTFX Trauma Bone Plate and Screw System approved by the FDA?

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

What company makes ARTFX Trauma Bone Plate and Screw System?

ARTFX Trauma Bone Plate and Screw System is manufactured by Artfx Medical.

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.

Related Clinical Trials

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Other Devices by Artfx Medical

K240889ARTFX Lumbar PEEK Cages K240893ARTFX MEDICAL Cervical PEEK Cages

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Official Source

View on FDA Database →

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

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