510(k) Report

Devices descending from K163491

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+1K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+1K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+1K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+1K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+1K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+1K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+1K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+1K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+1K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+1K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+1K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+1K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+2K263049SABER-C SystemElevation Spine20260—
+2K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+2K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+2K250560BEE HANGMedical GmbH20250—
+2K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+2K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+2K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+2K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+2K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+2K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+2K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+2K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+2K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+2K230583Tryptik TiSpineart SA20231—
+2K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+2K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+2K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+2K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+2K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+2K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+2K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+2K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+2K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+2K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+2K203444BEE HA CageNGMedical GmbH20211—
+2K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+2K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+2K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+2K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+2K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+2K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+2K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+2K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+2K200312Tryptik TiSpineart20202—
+2K192897icotec Cervical CageIcotec AG20201—
+2K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+2K191134IB3D AlifMedicrea International SA20191—
+2K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+2K190885Elevation Spine Saber-C SystemElevation Spine201925—
+2K190680Favo S-TlifSilony Medical GmbH20190—
+2K182608Oyster ACIF CageSilony Medical GmbH20190—
+2K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+2K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+2K182477Cervical SpacerAdditive Implants, LLC201915—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+2K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+3K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K260660SABER-C SystemElevation Spine20261—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+3K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K250540SABER-C SystemElevation Spine20252—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+3K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—