Cleared Traditional

TACTIX Vector Syndesmosis System

K240035 · Vilex, LLC · Orthopedic
Aug 2024
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K240035 is an FDA 510(k) clearance for the TACTIX Vector Syndesmosis System, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on August 1, 2024, 210 days after receiving the submission on January 4, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K240035 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2024
Decision Date August 01, 2024
Days to Decision 210 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTN — Washer, Bolt Nut
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030