FDA 510(k)

TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System

K-Number: K231504 · 2023-09-11

Decision Date2023-09-11

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System is a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2023-09-11 under approval number K231504. 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 TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System?

TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System is a medical device that received FDA 510(k) clearance on 2023-09-11. It is manufactured by Vilex, LLC. The 510(k) number is K231504.

When was TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System approved by the FDA?

TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System received FDA 510(k) clearance on 2023-09-11, under approval number K231504.

What company makes TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System?

TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System is manufactured by Vilex, LLC.

What is the FDA product code for TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System?

The FDA product code for TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System is HWC. This falls under the Cardiovascular category.

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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.