X-Guide Surgical Navigation System— 510(k) K253954

Name: FDA 510(k) clearance K253954
Creator: U.S. Food and Drug Administration
Published: 2026-08-28

Substantially Equivalent

X-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.

Clearance details

Applicant: X-Nav Technologies, LLC
Product code: Code QRY
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2025-12-10
Decision date: 2026-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansdale, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QRY

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K232148 — X-Guide Surgical Navigation System2024-02-21
K222750 — Yomi Robotic System2022-12-08
K222049 — Yomi Robotic System2022-11-04
K211701 — X-Guide® Surgical Navigation System2022-02-01

More clearances from X-Nav Technologies, LLC

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K200662 — X-Guide® Surgical Navigation System2020-05-21
K192579 — X-Guide Surgical Navigation System2020-02-03
K150222 — X-Guide Surgical Navigation System2015-10-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.