510(k) Report

Devices descending from K082262

722 later devices reach LDR Spine Roi Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+10K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+10K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+10K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+10K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+10K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+10K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+10K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+10K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+11K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+11K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+11K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+11K221578Hexanium ACIFSpinevision, S.A.S.20224—
+11K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+11K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+12K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+12K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+13K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—