510(k) Report

Devices descending from K000068

569 later devices reach Compumedics E-Series Eeg System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201327NavLock TrackersMedtronic Navigation20202—
+7K200705Nurochek SystemCryptych Pty, Ltd.20200—
+7K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+7K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+7K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+7K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+7K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+7K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+7K182227Esprit NovaNeurozone Msh Incorporated20190—
+7K182721Choice Spine Navigation SystemChoicespine, LP20192—
+7K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+7K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+7K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+7K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+7K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+7K172735WR19 SystemZeto, Inc.20183—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+7K170138NeuronauteBioserenity20170—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K171321K2M Navigation InstrumentsK2m201711
+7K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+7K162627EnsoSleepEnsodata, Inc.20179—
+7K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+7K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+7K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+7K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+7K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+7K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+8K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K260455New Wave SystemZeto, Inc.20260—
+8K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+8K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+8K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+8K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+8K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+8K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+8K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+8K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+8K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+8K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+8K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+8K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+8K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+8K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+8K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+8K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+8K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+8K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+8K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+8K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+8K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+8K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+8K221179SomnoMetryNeumetry Medical, Inc.20223—
+8K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+8K220056iSyncWaveiMediSync, Inc.20220—
+8K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+8K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+8K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—