Cleared Special

TACTIX Vector Syndesmosis System

K243408 · Vilex, LLC · Orthopedic
Nov 2024
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K243408 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 November 27, 2024, 26 days after receiving the submission on November 1, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243408 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2024
Decision Date November 27, 2024
Days to Decision 26 days
Submission Type Special
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