510(k) Report

Devices descending from K140003

453 later devices reach Coroent Small Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+1K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+1K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+1K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+1K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+2K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+2K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+2K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+2K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+2K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+2K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+2K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+2K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+2K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+2K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+2K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+2K162587Roccia® AcifSilony Medical GmbH20171—
+2K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+2K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+2K160125Cascadia Interbody SystemK2m2016315—
+2K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+2K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+3K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+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—
+3K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+3K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+3K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+3K182608Oyster ACIF CageSilony Medical GmbH20190—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+3K171312FortiCore®Nanovis, LLC20183—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+3K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K263049SABER-C SystemElevation Spine20260—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261049Scala® TLSpineart SA20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K250560BEE HANGMedical GmbH20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—