510(k) Report

Devices descending from K181881

4 later devices reach Outlet Sacroiliac Joint Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+1K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+1K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+2K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—