Vilex In Tennessee Inc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
7
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1721-2015Class IIVilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcanApril 22, 2015
Z-1723-2015Class IIVilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcanApril 22, 2015
Z-1722-2015Class IIVilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcanApril 22, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K191289Bone Screw Line AdditionJuly 29, 2019
K190543Cannulated Hemi ImplantMay 31, 2019
K163487Ultima HA Coated Half Pins and WireFebruary 13, 2017
K151881X-Fix Line AdditionsMarch 24, 2016
K150211EzFuze Implant SystemNovember 10, 2015
K151456Small Bone Nail ImplantOctober 29, 2015
K141937TRIDENT FUSION IMPLANTSeptember 10, 2014