510(k) Report

Devices descending from K073320

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+6K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+6K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223251Hexanium PLIFSpinevision, S.A.S.20220—
+6K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+6K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+6K203003Pantheon IBFDPantheon Spinal20210—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K201671A-Link ZAcuity Surgical Devices, LLC202125—
+6K200919Idys ALIF 3DTiClariance20210—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K200429BEE CagesNGMedical GmbH202111—
+6K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+6K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+6K193521Steerable Plateau TiLife Spine, Inc.20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K192993Scarlet AL-TSpineart20201—
+6K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+6K1803473d CageFims Co., Ltd.20190—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K183064TxTi IBF SystemInnovasis, Inc.2019481
+6K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911