INLIANT Surgical Navigation System— 510(k) K213392

Name: FDA 510(k) clearance K213392
Creator: U.S. Food and Drug Administration
Published: 2022-02-22

Substantially Equivalent

Navigate Surgical Technologies, Inc.

FDA 510(k) clearance K213392 for INLIANT Surgical Navigation System, Substantially Equivalent on 2022-02-22. Applicant: Navigate Surgical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Navigate Surgical Technologies, Inc.
Product code: Code PLV
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2021-10-15
Decision date: 2022-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

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