Vilex, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
29
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250304TITANEX Screw SystemsMarch 5, 2025
K240475Hintermann Series H2 Total Ankle SystemDecember 2, 2024
K243408TACTIX Vector Syndesmosis SystemNovember 27, 2024
K233816REDEMPTION Charcot Plating SystemAugust 28, 2024
K240035TACTIX Vector Syndesmosis SystemAugust 1, 2024
K231343Redemption Duo Hindfoot Nail SystemJanuary 30, 2024
K231504TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemSeptember 11, 2023
K231493NITINEX Memory Compression StapleAugust 11, 2023
K230462OPTIX H2 Patient Specific Instrument SystemJuly 17, 2023
K230204ALPHALOK Plating SystemApril 25, 2023
K221342REDEMPTION Beaming SystemDecember 13, 2022
K221558ALPHALOK Plating SystemNovember 15, 2022
K212348ALPHALOK™ Plating SystemMay 2, 2022
K212552Correx SoftwareOctober 12, 2021
K202143Dynex MicroSeptember 11, 2020
K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemAugust 24, 2020
K132820VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRESJuly 23, 2014
K112837VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)October 9, 2012
K102413FUZE: INTRAMEDULLARY INTERNAL FIXATION NAILNovember 14, 2011
K102401HEMI IMPLANT; MINI HEMI IMPLANTJuly 20, 2011