Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Vilex in Tennessee with 7 510(k) clearances, 3 device recalls and 1 warning letter. The most recent is a 510(k) clearance dated Jul 29, 2019: Bone Screw Line Addition.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 29, 2019 | Bone Screw Line AdditionK191289 · HWC | 510(k) clearances |
| May 31, 2019 | Cannulated Hemi ImplantK190543 · KWD | 510(k) clearances |
| Mar 15, 2019 | Warning letter: UnspecifiedCDRH | Warning letters |
| Feb 13, 2017 | Ultima HA Coated Half Pins and WireK163487 · JDW | 510(k) clearances |
| Mar 24, 2016 | X-Fix Line AdditionsK151881 · KTT | 510(k) clearances |
| Nov 10, 2015 | EzFuze Implant SystemK150211 · HWC | 510(k) clearances |
| Oct 29, 2015 | Small Bone Nail ImplantK151456 · HSB | 510(k) clearances |
| Apr 22, 2015 | Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.Class II · Incidence of breakage is higher than expected. | Device recalls |
| Apr 22, 2015 | Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.Class II · Incidence of breakage is higher than expected. | Device recalls |
| Apr 22, 2015 | Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.Class II · Incidence of breakage is higher than expected. | Device recalls |
| Sep 10, 2014 | TRIDENT FUSION IMPLANTK141937 · HWC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
