510(k) Report

Devices descending from K971819

464 later devices reach Epoch 2000 Neurological Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+8K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+8K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+8K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+8K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+8K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+8K213918DeGen Navigated InstrumentationDegen Medical20220—
+8K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+8K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+8K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+8K211596CD Horizon Spinal SystemMedtronic20213—
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K211323ASTRA Spine SystemSpinecraft, LLC202112—
+8K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+8K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+8K210306GII Spinal Fixation SystemColigne AG20210—
+8K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+8K210472SPINEART Navigation Instrument SystemSpineart20215—
+8K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+8K201327NavLock TrackersMedtronic Navigation20202—
+8K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+8K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+8K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+8K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+8K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+8K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+8K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+8K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+8K182721Choice Spine Navigation SystemChoicespine, LP20192—
+8K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+8K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+8K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+8K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+8K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+8K171321K2M Navigation InstrumentsK2m201711
+8K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+8K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+8K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+8K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+8K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+8K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+9K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+9K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+9K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+9K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+9K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+9K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+9K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+9K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+9K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+9K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+9K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+9K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+9K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+9K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+9K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+9K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+9K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+9K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+9K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—