510(k) Report

Devices descending from K231743

3 later devices reach F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+1K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+2K261809Interwedge® Standalone LateralFoundation Surgical Group20260—