510(k) Report

Devices descending from K150362

441 later devices reach NuVasive CoRoent Small Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+1K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+1K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+1K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+1K162587Roccia® AcifSilony Medical GmbH20171—
+1K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+1K160125Cascadia Interbody SystemK2m2016315—
+2K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+2K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+2K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+2K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+2K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+2K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+2K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+2K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+2K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+2K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+2K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+2K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+2K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K182608Oyster ACIF CageSilony Medical GmbH20190—
+2K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+2K182477Cervical SpacerAdditive Implants, LLC201915—
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+2K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+2K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+2K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+2K171312FortiCore®Nanovis, LLC20183—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+2K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+2K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+2K171140Matrixx SystemNexxt Spine, LLC2017145—
+2K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+2K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+2K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K163364MOJAVE Expandable Interbody SystemK2m201725—
+2K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K263049SABER-C SystemElevation Spine20260—
+3K261049Scala® TLSpineart SA20260—
+3K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+3K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K250560BEE HANGMedical GmbH20250—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+3K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+3K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+3K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K230583Tryptik TiSpineart SA20231—
+3K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+3K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+3K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+3K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191