510(k) Report

Devices descending from K120918

642 later devices reach Nuvasive Coroent Titanium System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230026SqualeImplanet, S.A.20230—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+7K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+7K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+7K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+7K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K192897icotec Cervical CageIcotec AG20201—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—