510(k) Report

Devices descending from K071833

963 later devices reach Mosaic Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+6K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+6K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+6K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K230583Tryptik TiSpineart SA20231—
+6K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+6K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+6K223251Hexanium PLIFSpinevision, S.A.S.20220—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K221172FOCUS Interbody SystemOc Medical Devices20220—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K213417Ghost Spacer SystemLife Spine, Inc.20220—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+6K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+6K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+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—
+6K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+6K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K200919Idys ALIF 3DTiClariance20210—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+6K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+6K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+6K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+6K191796Neo Cage SystemNeo Medical SA20190—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K190488ProLift Expandable SystemLife Spine, Inc.201916—
+6K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+6K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+6K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—