X-Guide® Surgical Navigation System— 510(k) K211701

Name: FDA 510(k) clearance K211701
Creator: U.S. Food and Drug Administration
Published: 2022-02-01

Substantially Equivalent

X-Nav Technologies, LLC

FDA 510(k) clearance K211701 for X-Guide® Surgical Navigation System, Substantially Equivalent on 2022-02-01. 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: 2021-06-03
Decision date: 2022-02-01
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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K253954 — X-Guide Surgical Navigation System2026-08-28
K232148 — X-Guide Surgical Navigation System2024-02-21
K222750 — Yomi Robotic System2022-12-08
K222049 — Yomi Robotic System2022-11-04

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

Recalls naming K211701

K-number listed on FDA's recall record

Z-0222-2023 — X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673Class II·Ongoing·X-NAV Technologies, LLC·20220928

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211701.

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