X-Guide Surgical Navigation System— 510(k) K150222

Name: FDA 510(k) clearance K150222
Creator: U.S. Food and Drug Administration
Published: 2015-10-08

Substantially Equivalent

X-Nav Technologies, LLC

FDA 510(k) clearance K150222 for X-Guide Surgical Navigation System, Substantially Equivalent on 2015-10-08. 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: 2015-01-30
Decision date: 2015-10-08
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
K192579 — X-Guide Surgical Navigation System2020-02-03

Recalls naming K150222

K-number listed on FDA's recall record

Z-1391-2016 — X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.Class II·Terminated·X-NAV Technologies, LLC·20160223

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150222.

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