510(k) Report

Devices descending from K172947

22 later devices reach HALF DOME Posterior Lumbar Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+1K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+1K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+1K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+2K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+2K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+2K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+2K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+2K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+2K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—