510(k) Report

Devices descending from K180814

18 later devices reach CoreLink® M3™ Stand-Alone Anterior Lumbar System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+1K230329F3D Interbody SystemCorelink, LLC20230—
+1K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+1K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+1K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+1K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+2K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+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—