FDA · official record K213392Substantially Equivalent

INLIANT Surgical Navigation System

Name: INLIANT Surgical Navigation System — FDA K213392
Creator: Navigate Surgical Technologies, Inc.
Keywords: INLIANT Surgical Navigation System, INLIANT Surgical Navigation System, K213392, PLV, FDA

United StatesPLVNavigate Surgical Technologies, Inc.

Verified

Official record identity

FDA application number: K213392
Decision date: February 22, 2022
Published decision: Substantially Equivalent

Classification

Product code: PLV

Published parties

Applicant: Navigate Surgical Technologies, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2021-10-15
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4120

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.