FDA applicant

Vilex IN Tennessee, Inc.

Mcminnville, TN7 decisions2014–20192 recalls

FDA records 7 decisions for Vilex IN Tennessee, Inc. (Mcminnville, TN) from 2014 to 2019: 7 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and KTT (Appliance, Fixation, Nail/Blade/Plate…). Its devices cite 35 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Vilex IN Tennessee, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2014high 2 (2015) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2022

2014high 2 (2022) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Vilex IN Tennessee, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vilex IN Tennessee, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Vilex”

FDA records each applicant name separately; these may or may not be the same firm.

Vilex, LLC 30

Vilex IN Tennessee, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Vilex”