510(k) Report

Devices descending from K152968

83 later devices reach Arsenal Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+1K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+1K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+1K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+1K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+1K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+1K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+1K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+1K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+2K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+2K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+2K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+2K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+2K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+2K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+2K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+2K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+2K180324Patriot Spinal Fixation SystemValorus Spine20180—
+2K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+2K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+2K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+3K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—