K243408

TACTIX Vector Syndesmosis System

510(k) number
K243408
Device name
TACTIX Vector Syndesmosis System
Applicant
Vilex, LLC TN · US
Product code
HTN — Washer, Bolt Nut
Decision date
2024-11-27
Date received
2024-11-01
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain

Also available from FDA: K243408.pdf

Official FDA record: K243408
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.