X-Guide P008542
by X-Nav Technologies, LLC 18 variants
X-Guide P008542 is a surgical planning/navigation-enhancement system (FDA Class II) made by X-Nav Technologies, LLC, cleared under FDA 510(k) K232148 on 21 Feb 2024 and listed in FDA GUDID since 5 Sep 2024 (UDI-DI 00817421022753), active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817421022753 | Date5 Sep 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232148 | Date21 Feb 2024 | StatusActive |
Official records
- AccessGUDID record 00817421022753
- FDA 510(k) database K232148
Across registries
- FDA 510(k) K232148 decided 21 Feb 2024 Active
- FDA GUDID UDI-DI 00817421022753 listed 5 Sep 2024 Listed
Recalls
-
- Ongoing Z-1393-2024
- Ongoing Z-1392-2024
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.
Timeline
- Cleared FDA 510(k) K232148
- Recall initiated FDA recalls Z-1393-2024
- Recall initiated FDA recalls Z-1392-2024
- Listed FDA GUDID 00817421022753
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- Withdrawn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 / reference
- P008542
- Primary DI / UDI-DI
- 00817421022753
- 510(k) Number
- FDA product code
- PLV, QRY
- GMDN term
- Surgical planning/navigation-enhancement system
- Device class
- Class II
- Regulation number
- 872.4120
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Surgical planning/navigation-enhancement system.