510(k) Report

Devices descending from K962796

429 later devices reach Neuroguard Transcranial Doppler Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+6K210306GII Spinal Fixation SystemColigne AG20210—
+6K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+6K210472SPINEART Navigation Instrument SystemSpineart20215—
+6K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K201327NavLock TrackersMedtronic Navigation20202—
+6K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+6K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+6K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+6K182721Choice Spine Navigation SystemChoicespine, LP20192—
+6K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+6K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+6K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171321K2M Navigation InstrumentsK2m201711
+6K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+6K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+7K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+7K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+7K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+7K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+7K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+7K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+7K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+7K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+7K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+7K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+7K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+7K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+7K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+7K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+7K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+7K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+7K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+7K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+7K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+7K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—