510(k) Report

Devices descending from K163440

3 later devices reach Stealth Staple System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+1K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+2K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—