510(k) Report

Devices descending from K151214

220 later devices reach ALIF Interfixated System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+1K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+1K180695FBC 921 (Alif)Fbc Device Aps20180—
+1K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+1K163595IMPIX 3D Print CagesMedicrea International SA2017282
+1K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+1K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K230329F3D Interbody SystemCorelink, LLC20230—
+2K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+2K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+2K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+2K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+2K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+2K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+2K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+2K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+2K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+2K192993Scarlet AL-TSpineart20201—
+2K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+2K191134IB3D AlifMedicrea International SA20191—
+2K190680Favo S-TlifSilony Medical GmbH20190—
+2K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+2K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+2K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+2K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+3K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+3K242589Scarlet® AL-TSpineart SA20240—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+3K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+3K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+3K200316UNiD IB3D ALIFMedicrea International SA20200—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+4K250556Porous Biologic ScaffoldVentris Medical20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+4K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+4K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K240442MagnetOs PuttyKuros Biosciences B.V20243—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K240458Synthetic Bone PuttyVentris Medical20242—
+4K240459Cerament Bone Void FillerBonesupport AB20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K232347MagnetOs GranulesKuros Biosciences B.V20242—
+4K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+4K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+4K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—