X-Guide P009350
X-Guide P009350 is a Class II device made by X-Nav Technologies, LLC, cleared under FDA 510(k) K150222 on 8 Oct 2015 and listed in FDA GUDID since 22 May 2018 (UDI-DI 00817421020728), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817421020728 | Date22 May 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150222 | Date8 Oct 2015 | StatusActive |
Official records
- AccessGUDID record 00817421020728
- FDA 510(k) database K150222
Across registries
- FDA 510(k) K150222 decided 8 Oct 2015 Active
- FDA GUDID UDI-DI 00817421020728 listed 22 May 2018 Listed
Recalls
-
- Terminated Z-1391-2016
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
Timeline
- Cleared FDA 510(k) K150222
- Recall initiated FDA recalls Z-1391-2016
- Listed FDA GUDID 00817421020728
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- X-Guide
- Generic name
- Surgical planning/navigation-enhancement system
- Model / Ref / Catalog
- P009350
- Primary DI / UDI-DI
- 00817421020728
- 510(k) Number
- FDA product code
- PLV
- GMDN term
- Surgical planning/navigation-enhancement system
- Device class
- Class II
- Regulation number
- 872.4120
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Surgical planning/navigation-enhancement system.