510(k) Report

Devices descending from K183239

8 later devices reach CoreLink F3D™ Lateral System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+1K230329F3D Interbody SystemCorelink, LLC20230—
+1K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+2K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+2K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+2K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+2K223326Axiom PSR SystemRestor3D202301
+3K261809Interwedge® Standalone LateralFoundation Surgical Group20260—