510(k) Report

Devices descending from K032476

753 later devices reach Nuvasive Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K130699Aleutian Spinal SystemK2m, Inc.2013570—
+4K123388K7C SpacerK7, LLC20130—
+4K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+4K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+4K113138Aleutian SystemK2m, Inc.2012549—
+4K112664Zavation Ibf SystemsZavation, LLC201137—
+4K103169AleuttianK2m, Inc.2011572—
+4K101302Aleutian Ibf SystemK2m, Inc.2010595—
+5K261049Scala® TLSpineart SA20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K243670Idys® LIFClariance20240—
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+5K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+5K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K212831MectaLIF ExtensionMedacta International S.A.20211—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K201793EDEN Peek CageJmt Co., Ltd.20210—
+5K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K202380Born PT-LIF Cage HASpineworxx AG20210—
+5K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192117Small VBR™Ulrich GmbH & Co. KG20196—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+5K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+5K183259Idys™ TLIF TiVacClariance, Sas20191—
+5K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K182584Lucent® XPSpinal Elements, Inc.20183—
+5K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+5K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+5K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K171312FortiCore®Nanovis, LLC20183—
+5K173702Juliet Ti LLSpineart20182—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711