Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TACTIX Vector Syndesmosis System

K-Number: K243408 · 2024-11-27

ApplicantVilex, LLC
Decision Date2024-11-27
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TACTIX Vector Syndesmosis System is a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2024-11-27 under approval number K243408. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TACTIX Vector Syndesmosis System?

TACTIX Vector Syndesmosis System is a medical device that received FDA 510(k) clearance on 2024-11-27. It is manufactured by Vilex, LLC. The 510(k) number is K243408.

When was TACTIX Vector Syndesmosis System approved by the FDA?

TACTIX Vector Syndesmosis System received FDA 510(k) clearance on 2024-11-27, under approval number K243408.

What company makes TACTIX Vector Syndesmosis System?

TACTIX Vector Syndesmosis System is manufactured by Vilex, LLC.

What is the FDA product code for TACTIX Vector Syndesmosis System?

The FDA product code for TACTIX Vector Syndesmosis System is HTN.

Other Devices by Vilex, LLC

View all 17 devices →

Related Devices (Code: HTN)

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.