X-NAV Technologies, LLC
FDA Regulatory Profile
X-NAV Technologies, LLC appears in FDA public data with 4 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1392-2024, Class II) was initiated on March 4, 2024. Its most recent 510(k) clearance was granted on February 21, 2024.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1392-2024 | Class II | X-Guide Handpiece Adaptor Sleeve 1, Model P010701 | March 4, 2024 |
| Z-1393-2024 | Class II | X-Guide Handpiece Adaptor Sleeve 3, Model P010727 | March 4, 2024 |
| Z-0222-2023 | Class II | X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XM | September 28, 2022 |
| Z-1391-2016 | Class II | X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a c | February 23, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232148 | X-Guide Surgical Navigation System | February 21, 2024 |
| K211701 | X-Guide® Surgical Navigation System | February 1, 2022 |
| K200662 | X-Guide® Surgical Navigation System | May 21, 2020 |
| K192579 | X-Guide Surgical Navigation System | February 3, 2020 |
| K150222 | X-Guide Surgical Navigation System | October 8, 2015 |