X-NAV Technologies, LLC
Lansdale, PA, US
X-NAV TECHNOLOGIES, LLC. appears in FDA device records in Lansdale, PA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for X-NAV Technologies, LLC between 2015 and 2024. The busiest year on record is 2020, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2020 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232148 | X-Guide Surgical Navigation System | QRY | Substantially Equivalent | |
| K211701 | X-Guide® Surgical Navigation System | QRY | Substantially Equivalent | |
| K200662 | X-Guide® Surgical Navigation System | PLV | Substantially Equivalent | |
| K192579 | X-Guide Surgical Navigation System | PLV | Substantially Equivalent | |
| K150222 | X-Guide Surgical Navigation System | PLV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011764595 | 3011764595 | X-NAV TECHNOLOGIES, LLC. | 1555 Bustard Road, Suite 75 & 110, Lansdale, PA 19446 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1393-2024 | X-Guide Handpiece Adaptor Sleeve 3, Model P010727 | The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece. | Class II | Open, Classified | |
| Z-1392-2024 | X-Guide Handpiece Adaptor Sleeve 1, Model P010701 | The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece. | Class II | Open, Classified | |
| Z-0222-2023 | X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673 | Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip. | Class II | Open, Classified | |
| Z-1391-2016 | 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 and the intra-operative surgical phase of dental implantation procedures. | The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures. The X-Clip contains three fiducial markers made from a Stainless Steel material. The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain