510(k) Report

Devices descending from K111123

196 later devices reach Varilift Cervical Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+1K120603Varilift -CWenzel Spine2013193—
+2K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+2K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+2K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+2K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+2K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+4K201287Impulse Interbody Fusion SystemDegen Medical20208—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+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—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K223418DeGen Impulse AM™ SystemDegen Medical20236—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—