510(k) Report

Devices descending from K081611

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+1K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+1K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+1K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+1K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+1K151651NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated201568—
+1K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+1K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+1K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+1K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+1K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+1K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+1K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+1K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+1K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+1K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+1K110915Cervical CageEisertech, LLC201123—
+1K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+2K253158VyBrate™ VBR SystemVy Spine, 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—
+2K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+2K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+2K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+2K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+2K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+2K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+2K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+2K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+2K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+2K191778Omnia Medical VBROmnia Medical, LLC20195—
+2K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+2K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+2K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+2K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+2K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+2K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+2K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+2K162587Roccia® AcifSilony Medical GmbH20171—
+2K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+2K160125Cascadia Interbody SystemK2m2016315—
+2K152568C-VBRCardinal Spine, LLC201657—
+2K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+2K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+2K141135Juliet LLSpineart2014146—
+2K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+2K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K122444Cervical CageEisertech, LLC201222—
+3K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+3K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+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—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+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—
+3K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+3K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+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—
+3K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+3K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+3K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—