FDA.report

510(k) K240035

Device
TACTIX Vector Syndesmosis System
Applicant
Vilex, LLC
510(k) number
K240035
Product code
HTN
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-01
Date received
2024-01-04
Regulation
888.3030
Classification name
Washer, Bolt Nut
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Brock Johnson
Address
111 Moffitt St. Mcminnville TN US 37110 37110

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00841731133861TACTIX VectorVILEX LLC2025-08-06

Other 510(k) Records For Product Code HTN

510(k)DeviceApplicantDecision date
K252081SportLinc Syndesmosis DeviceLincotek Medical2026-03-27
K253727Syndesmosis TightRope PROArthrex, Inc.2025-12-22
K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)2025-10-29
K251134RipCordTriMed, Inc.2025-07-11
K243624Acu-Sinch Knotless MiniAcumed, LLC2025-01-23
K242091Bolo Button SystemFusion Orthopedics2024-12-23
K243408TACTIX Vector Syndesmosis SystemVilex, LLC2024-11-27
K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.2024-11-01
K240947TENSOR® Suture Button SystemGlobus Medical, Inc.2024-06-03
K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company2024-02-02
K232780CC-Clip® Implant SystemCc-Instruments, Inc.2023-12-18
K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.2023-10-06
K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.2022-08-22
K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.2022-06-06
K220650TriMed Ripcord DeviceTriMed, Inc.2022-06-01