X-Guide Surgical Navigation System— 510(k) K192579

Name: FDA 510(k) clearance K192579
Creator: U.S. Food and Drug Administration
Published: 2020-02-03

Substantially Equivalent

X-Nav Technologies, LLC

FDA 510(k) clearance K192579 for X-Guide Surgical Navigation System, Substantially Equivalent on 2020-02-03. Applicant: X-Nav Technologies, LLC. Device class: 2.

Clearance details

Applicant: X-Nav Technologies, LLC
Product code: Code PLV
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2019-09-19
Decision date: 2020-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansdale, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from X-Nav Technologies, LLC

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K253954 — X-Guide Surgical Navigation System2026-08-28
K232148 — X-Guide Surgical Navigation System2024-02-21
K211701 — X-Guide® Surgical Navigation System2022-02-01
K200662 — X-Guide® Surgical Navigation System2020-05-21
K150222 — X-Guide Surgical Navigation System2015-10-08

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