510(k) Report

Devices descending from K010530

1,764 later devices reach Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+6K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K240715Idys® C ZP 3DTiClariance20240—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+6K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+6K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+6K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+6K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+6K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+6K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K230026SqualeImplanet, S.A.20230—
+6K230583Tryptik TiSpineart SA20231—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+6K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+6K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K221578Hexanium ACIFSpinevision, S.A.S.20224—
+6K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+6K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K222561AlignAcuity Surgical Devices, LLC202214—
+6K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K220610SOLO-LAurora Spine, Inc.20220—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+6K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—