Medical Device Manufacturer · US , Mcminnville , TN

Vilex, LLC - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2020

Recent clearances: DYNEX® External Fixation Systems, TITANEX Screw Systems, Hintermann Series H2 Total Ankle System

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17
Total
17
Cleared
0
Denied

FDA 510(k) Regulatory Record - Vilex, LLC Orthopedic ✕

17 devices
1-17 of 17
Cleared Apr 17, 2026
DYNEX® External Fixation Systems
K260900 · KTT
Orthopedic · 30d
Cleared Mar 05, 2025
TITANEX Screw Systems
K250304 · HWC
Orthopedic · 30d
Cleared Dec 02, 2024
Hintermann Series H2 Total Ankle System
K240475 · HSN
Orthopedic · 286d
Cleared Nov 27, 2024
TACTIX Vector Syndesmosis System
K243408 · HTN
Orthopedic · 26d
Cleared Aug 28, 2024
REDEMPTION Charcot Plating System
K233816 · HRS
Orthopedic · 272d
Cleared Aug 01, 2024
TACTIX Vector Syndesmosis System
K240035 · HTN
Orthopedic · 210d
Cleared Jan 30, 2024
Redemption Duo Hindfoot Nail System
K231343 · HSB
Orthopedic · 266d
Cleared Sep 11, 2023
TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
K231504 · HWC
Orthopedic · 110d
Cleared Aug 11, 2023
NITINEX Memory Compression Staple
K231493 · JDR
Orthopedic · 80d
Cleared Jul 17, 2023
OPTIX H2 Patient Specific Instrument System
K230462 · HSN
Orthopedic · 146d
Cleared Apr 25, 2023
ALPHALOK Plating System
K230204 · HRS
Orthopedic · 90d
Cleared Dec 13, 2022
REDEMPTION Beaming System
K221342 · HWC
Orthopedic · 218d
Cleared Nov 15, 2022
ALPHALOK Plating System
K221558 · HRS
Orthopedic · 168d
Cleared May 02, 2022
ALPHALOK™ Plating System
K212348 · HRS
Orthopedic · 278d
Cleared Oct 12, 2021
Correx Software
K212552 · KTT
Orthopedic · 60d
Cleared Sep 11, 2020
Dynex Micro
K202143 · KTT
Orthopedic · 42d
Cleared Aug 24, 2020
Dynex Ring Fixation System, Diametrix Ring Fixation System
K202054 · KTT
Orthopedic · 31d
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