510(k) Report

Devices descending from K003589

882 later devices reach Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K130617RaystationRaysearch Laboratories AB2013216
+6K121936NaviopfsBlue Belt Technologies, Inc.2012222
+6K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+6K103829Kneealign SystemOrthalign, Inc.201139—
+6K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+7K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K261852OTS HipOrtoma AB20260—
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+7K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+7K254265Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS…Brainlab AG20250—
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+7K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20251—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242271Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20240—
+7K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+7K242616Lantern® HipOrthalign, Inc.20241—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+7K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+7K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+7K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+7K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG202411
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K230415Cadwell GuardianCadwell Industries, Inc.20230—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K220072Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd.20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+7K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+7K222803OncospaceOncospace, Inc.20233—
+7K223351Naviswiss KneeNaviswiss AG20230—
+7K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+7K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+7K220554Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20220—
+7K214065ROSA ONE Brain applicationMedtech S.A.S20221—
+7K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+7K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K210153NextAR RSA PlatformMedacta International S.A.202151
+7K203679Automatic RegistrationBrainlab AG20211—
+7K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+7K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Brainlab AG20209—
+7K200655FibroScan® 630Echosens20200—
+7K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+7K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—
+7K201053PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20201—
+7K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+7K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+7K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+7K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+7K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+7K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K180394BrightMatter Plan 1.6.0Synaptive Medical, Inc.20180—
+7K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+7K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+7K172886Breakaway Screw SystemParagon 2820174—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K171677Clear Guide SCENERGYClear Guide Medical20173—
+7K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+7K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+7K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+7K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+7K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+7K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.201714Class I
+7K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+7K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+7K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+7K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+7K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+7K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+7K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—