510(k) Report

Devices descending from K020400

468 later devices reach Digitimer D185 Multipulse Cortical Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+6K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K231184CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20230—
+6K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+6K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+6K213815SiJoin®T3Vgi Medical, Inc.20230—
+6K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+6K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+6K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+6K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+6K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+6K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K213918DeGen Navigated InstrumentationDegen Medical20220—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+6K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+6K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+6K211596CD Horizon Spinal SystemMedtronic20213—
+6K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+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—
+6K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+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—