510(k) Report

Devices descending from K150847

29 later devices reach Foundation Interbody Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+1K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+1K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+1K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+2K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+2K230329F3D Interbody SystemCorelink, LLC20230—
+2K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+2K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+2K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+2K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+2K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+3K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+3K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+3K223326Axiom PSR SystemRestor3D202301
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—