510(k) Report

Devices descending from K191995

2 later devices reach S4 Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+1K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—