Company · US
X-Nav Technologies, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (1 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2026 | K253954 | X-Guide Surgical Navigation System X-Nav Technologies, LLC | QRY |
| Feb 21, 2024 | K232148 | X-Guide Surgical Navigation System X-Nav Technologies, LLC | QRY |
| Feb 1, 2022 | K211701 | X-Guide® Surgical Navigation System X-Nav Technologies, LLC | QRY |
| May 21, 2020 | K200662 | X-Guide® Surgical Navigation System X-Nav Technologies, LLC | PLV |
| Feb 3, 2020 | K192579 | X-Guide Surgical Navigation System X-Nav Technologies, LLC | PLV |
| Oct 8, 2015 | K150222 | X-Guide Surgical Navigation System X-Nav Technologies, LLC | PLV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2024 | X-NAV Technologies, LLC X-Guide Handpiece Adaptor Sleeve 3, Model P010727 Open, Classified |
QRY | K232148 |
| Mar 29, 2024 | X-NAV Technologies, LLC X-Guide Handpiece Adaptor Sleeve 1, Model P010701 Open, Classified |
QRY | K232148 |
| Nov 10, 2022 | X-NAV Technologies, LLC X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration.
Catalog Number:P010673 Open, Classified |
QRY | K211701 |
| Feb 23, 2016 | X-NAV Technologies, LLC X-Guide Surgical Navigation System, X-Clip Bulk Kit
The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase Terminated |
PLV | K150222 |