510(k) Report

Devices descending from DEN240014

3 later devices reach ARC-EX System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253638xStep (xStep)Spinex, Inc.20260—
+1K252893ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure®…Aneuvo20260—
+1K251821ARC-EX SystemOnward Medical, Inc.20250—