TITANEX Screw Systems
K-Number: K250304 · 2025-03-05
ApplicantVilex, LLC
Decision Date2025-03-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TITANEX Screw Systems is a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2025-03-05 under approval number K250304. 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 Screw Systems?
TITANEX Screw Systems is a medical device that received FDA 510(k) clearance on 2025-03-05. It is manufactured by Vilex, LLC. The 510(k) number is K250304.
When was TITANEX Screw Systems approved by the FDA?
TITANEX Screw Systems received FDA 510(k) clearance on 2025-03-05, under approval number K250304.
What company makes TITANEX Screw Systems?
TITANEX Screw Systems is manufactured by Vilex, LLC.
What is the FDA product code for TITANEX Screw Systems?
The FDA product code for TITANEX Screw Systems 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.