X-Guide Surgical Navigation System— 510(k) K253954
Substantially EquivalentX-Nav Technologies, LLC
FDA 510(k) clearance K253954 for X-Guide Surgical Navigation System, Substantially Equivalent on 2026-08-28. Applicant: X-Nav Technologies, LLC. Device class: 2.
Summary
X-Nav Technologies filed the X-Guide Surgical Navigation System under product code QRY, dental navigation systems. Beyond the name and code, the record has no description of the system.
Class II, 21 CFR 872.4120. Dental is both the classification panel and the review panel. The submission was a Traditional 510(k).
X-Nav filed from Lansdale, Pennsylvania. The decision came 261 calendar days after FDA received it (December 10, 2025 to August 28, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- X-Nav Technologies, LLC
- Product code
- Product code QRY
- Device class
- Class 2
- Regulation
- 21 CFR 872.4120
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lansdale, PA, US
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