Vilex In Tennessee Inc
FDA Regulatory Profile
Vilex In Tennessee Inc appears in FDA public data with 3 recalls, 7 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1723-2015, Class II) was initiated on April 22, 2015. Its most recent 510(k) clearance was granted on July 29, 2019.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 7
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1723-2015 | Class II | Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcan | April 22, 2015 |
| Z-1721-2015 | Class II | Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcan | April 22, 2015 |
| Z-1722-2015 | Class II | Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcan | April 22, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K191289 | Bone Screw Line Addition | July 29, 2019 |
| K190543 | Cannulated Hemi Implant | May 31, 2019 |
| K163487 | Ultima HA Coated Half Pins and Wire | February 13, 2017 |
| K151881 | X-Fix Line Additions | March 24, 2016 |
| K150211 | EzFuze Implant System | November 10, 2015 |
| K151456 | Small Bone Nail Implant | October 29, 2015 |
| K141937 | TRIDENT FUSION IMPLANT | September 10, 2014 |