VGI Medical, LLC
FDA Regulatory Profile
VGI Medical, LLC appears in FDA public data with 1 recall, 1 510(k) clearance, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2100-2018, Class II) was initiated on April 9, 2018. Its most recent 510(k) clearance was granted on March 29, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2100-2018 | Class II | VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit | April 9, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213815 | SiJoin®T3 | March 29, 2023 |