510(k) Report

Devices descending from K071795

1,122 later devices reach Nuvasive Coroent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker 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—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K261067BEE PLIF CageNGMedical GmbH20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+4K242303MOD-COrthomod, LLC20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+4K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K250560BEE HANGMedical GmbH20250—
+4K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+4K252742Navigated InstrumentsTyber Medical, LLC20251—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+4K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+4K250556Porous Biologic ScaffoldVentris Medical20250—
+4K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+4K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+4K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K242589Scarlet® AL-TSpineart SA20240—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+4K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+4K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+4K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K240442MagnetOs PuttyKuros Biosciences B.V20243—
+4K234150Lucent® XPSpinal Elements20240—
+4K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K240458Synthetic Bone PuttyVentris Medical20242—
+4K240459Cerament Bone Void FillerBonesupport AB20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K232347MagnetOs GranulesKuros Biosciences B.V20242—
+4K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+4K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+4K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+4K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+4K232069Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd.20230—
+4K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+4K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—