510(k) Report

Devices descending from K143616

469 later devices reach AccuLIF TL and PL Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K240442MagnetOs PuttyKuros Biosciences B.V20243—
+5K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+5K240458Synthetic Bone PuttyVentris Medical20242—
+5K240459Cerament Bone Void FillerBonesupport AB20240—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K232347MagnetOs GranulesKuros Biosciences B.V20242—
+5K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+5K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+5K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+5K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+5K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K232315Catalyst Bone Void FillerOssdsign AB20237—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K223326Axiom PSR SystemRestor3D202301
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+5K223251Hexanium PLIFSpinevision, S.A.S.20220—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+5K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+5K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K203003Pantheon IBFDPantheon Spinal20210—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K202637F3D Corpectomy SystemCorelink, LLC20201—
+5K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—