510(k) Report

Devices descending from K050058

727 later devices reach Theken Reveal VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+10K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+10K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+10K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+10K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+10K230026SqualeImplanet, S.A.20230—
+10K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+10K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+10K203003Pantheon IBFDPantheon Spinal20210—
+10K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+10K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+10K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+11K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+11K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+11K221578Hexanium ACIFSpinevision, S.A.S.20224—
+11K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—