510(k) Report

Devices descending from K073320

1,018 later devices reach Cimplicity Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K211740DualXAmplify Surgical, Inc.20211—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K202380Born PT-LIF Cage HASpineworxx AG20210—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K200312Tryptik TiSpineart20202—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K192897icotec Cervical CageIcotec AG20201—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+4K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K182584Lucent® XPSpinal Elements, Inc.20183—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+4K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K171312FortiCore®Nanovis, LLC20183—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K172065Scarlet AC-TSpineart20172—
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+4K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K162531Sterispine CCSafe Orthopaedics20160—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—