TACTIX Vector Syndesmosis System— 510(k) K243408

Substantially Equivalent

Vilex, LLC

FDA 510(k) clearance K243408 for TACTIX Vector Syndesmosis System, Substantially Equivalent on 2024-11-27. Applicant: Vilex, LLC.

Clearance details

Applicant: Vilex, LLC
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 2024-11-01
Decision date: 2024-11-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Mcminnville, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.