FDA applicant
Vilex, LLC
FDA records 30 decisions for Vilex, LLC (Mcminnville, TN) from 1998 to 2026: 30 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and KTT (Appliance, Fixation, Nail/Blade/Plate…). Since 2016 its 510(k)s took a median of 110 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 66 predicates, 21 of them its own earlier devices. 3 recalls are linked to its devices.
FDA’s records also spell it “Vilex, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vilex, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
3in 2015
Class I Class II/III not classified
Planning a device like Vilex, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Vilex”
FDA records each applicant name separately; these may or may not be the same firm.