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X-Guide
XNAV TECHNOLOGIES LLC · Model P010871 · UDI-DI 00817421021237
PLV
Prescription
2
510(k) clearances
85
Adverse events
6
Recalls
6
Facilities
Description
TRACKER ARM ASSEMBLY, EDX, ANTERIOR UR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-10-30 | Neocis, Inc. | The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled. |
| 2020-05-14 | Neocis Inc. | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. |
| 2020-05-14 | Neocis Inc. | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. |
| 2020-05-14 | Neocis Inc. | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. |
| 2019-10-04 | Neocis Inc. | The Fiducial Array may mismatch their measurement files resulting in failed landmark check. |
| 2016-02-23 | X-NAV Technologies, LLC | 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 patien |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.