510(k) Report

Devices descending from K152512

33 later devices reach Half Dome Posterior Lumbar Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+1K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+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—
+1K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+1K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+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—
+2K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+2K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+2K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+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—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223418DeGen Impulse AM™ SystemDegen Medical20236—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—