510(k) Report

Devices descending from K192006

14 later devices reach SIRION Lateral Lumbar Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+1K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+1K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+1K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+2K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+2K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+2K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+2K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+2K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+2K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+2K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+2K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—