510(k) Report

Devices descending from K090782

134 later devices reach Novel Alif Spinal Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+1K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+1K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+1K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+1K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+1K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+1K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+2K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+2K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+2K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+2K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+2K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+2K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+2K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+2K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+2K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+2K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+2K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K212930LumiVy Lumbar IBF SystemVy Spine, LLC20226—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+3K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+4K223418DeGen Impulse AM™ SystemDegen Medical20236—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—