Medical Device Manufacturer · US , Mcminnville , TN

Vilex, LLC

16 submissions · 16 cleared · Since 2020
16
Total
16
Cleared
0
Denied

Vilex, LLC — FDA 510(k) Submissions

Vilex, LLC has submitted 16 FDA 510(k) premarket notifications since 2020, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Screw, Fixation, Bone, Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer, Washer, Bolt Nut . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
TITANEX Screw Systems
K250304 · HWC Screw, Fixation, Bone · Orthopedic
Mar 2025 30d
Hintermann Series H2 Total Ankle System
K240475 · HSN Prosthesis, Ankle,... · Orthopedic
Dec 2024 286d
TACTIX Vector Syndesmosis System
K243408 · HTN Washer, Bolt Nut · Orthopedic
Nov 2024 26d
REDEMPTION Charcot Plating System
K233816 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2024 272d
TACTIX Vector Syndesmosis System
K240035 · HTN Washer, Bolt Nut · Orthopedic
Aug 2024 210d
Redemption Duo Hindfoot Nail System
K231343 · HSB Rod, Fixation,... · Orthopedic
Jan 2024 266d
TITANEX? MICROBEAM Screw System, TITANEX? ARTEMIS Screw System
K231504 · HWC Screw, Fixation, Bone · Orthopedic
Sep 2023 110d
NITINEX Memory Compression Staple
K231493 · JDR Staple, Fixation, Bone · Orthopedic
Aug 2023 80d
OPTIX H2 Patient Specific Instrument System
K230462 · HSN Prosthesis, Ankle,... · Orthopedic
Jul 2023 146d
ALPHALOK Plating System
K230204 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2023 90d
REDEMPTION Beaming System
K221342 · HWC Screw, Fixation, Bone · Orthopedic
Dec 2022 218d
ALPHALOK Plating System
K221558 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2022 168d
ALPHALOK? Plating System
K212348 · HRS Plate, Fixation, Bone · Orthopedic
May 2022 278d
Correx Software
K212552 · KTT Appliance, Fixation,... · Orthopedic
Oct 2021 60d
Dynex Micro
K202143 · KTT Appliance, Fixation,... · Orthopedic
Sep 2020 42d
Dynex Ring Fixation System, Diametrix Ring Fixation System
K202054 · KTT Appliance, Fixation,... · Orthopedic
Aug 2020 31d
Filters
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