510(k) Report

Devices descending from K141665

588 later devices reach NuVasive CoRoent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+4K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+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—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+4K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+4K201087CORBEL SpacersGlobus Medical, Inc.202036—
+4K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+4K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+4K200312Tryptik TiSpineart20202—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K192993Scarlet AL-TSpineart20201—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+4K191134IB3D AlifMedicrea International SA20191—
+4K1803473d CageFims Co., Ltd.20190—
+4K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K182584Lucent® XPSpinal Elements, Inc.20183—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+4K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+4K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+5K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+5K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—