FDA 510(k) Application Details - K213392

Device Classification Name	More FDA Info for this Device
510(K) Number	K213392
Device Name	INLIANT Surgical Navigation System
Applicant	Navigate Surgical Technologies Inc. 302 - 25 E. 6th Ave. Vancouver V5T 1J3 CA Other 510(k) Applications for this Company
Contact	Marty Dymek Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2021
Decision Date	02/22/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review