510(k) Report

Devices descending from K150222

26 later devices reach X-Guide Surgical Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213392INLIANT Surgical Navigation SystemNavigate Surgical Technologies, Inc.20220—
+1K200805Neocis Guidance System (NGS) with Patient SplintsNeocis, Inc.20201—
+1K200662X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC20200—
+1K192579X-Guide Surgical Navigation SystemX-Nav Technologies, LLC20203—
+1K161399Neocis Guidance SystemNeocis, Inc.2016151
+1K161406NavidentClaronav, Inc.20161—
+2K210947NavidentClaronav, Inc.20220—
+2K211701X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC202221
+2K211129Neocis Guidance System (NGS) with Intraoral Fiducial ArrayNeocis, Inc.20210—
+2K203401Neocis Guidance System (NGS) with Patient Splints (EPS)Neocis, Inc.20200—
+2K202264Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc.20207—
+2K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc.201854
+3K232148X-Guide Surgical Navigation SystemX-Nav Technologies, LLC202412
+3K211466Yomi Robotic System with YomiPlan GoNeocis, Inc.20220—
+3K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc.20215—
+3K202100Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)Neocis, Inc.20200—
+3K200348Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)Neocis, Inc.20200—
+3K182776Neocis Guidance SystemNeocis, Inc.20182—
+4K253954X-Guide Surgical Navigation SystemX-Nav Technologies, LLC20260—
+4K222049Yomi Robotic SystemNeocis, Inc.20224—
+4K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsNeocis, Inc.20190—
+4K191605Neocis Guidance System (NGS)Neocis, Inc.20190—
+5K222750Yomi Robotic SystemNeocis, Inc.20223—
+6K231018Yomi Robotic SystemNeocis, Inc.20232—
+7K252376Yomi S Robotic SystemNeocis, Inc.20250—
+7K251835Yomi Robotic SystemNeocis, Inc.20250—