510(k) Report

Devices descending from K914571

884 later devices reach Neurotrac II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+9K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+9K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+9K252437JAZZ Spinal SystemImplanet20250—
+9K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+9K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+9K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+9K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+9K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+9K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+9K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+9K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+9K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+9K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K241397HinscopeHinlab Sas20240—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+9K241895Cannulated PsiFGuardSpineguard20240—
+9K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+9K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+9K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K240963Spinal SystemTeslake, Inc.20240—
+9K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+9K240392JAZZ Spinal SystemImplanet20241—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+9K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+9K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+9K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+9K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+9K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+9K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+9K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—
+9K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+9K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+9K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+9K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+9K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+9K231184CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20230—
+9K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+9K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+9K213815SiJoin®T3Vgi Medical, Inc.20230—
+9K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+9K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+9K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+9K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+9K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+9K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+9K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+9K222550Current Health SystemCurrent Health, Ltd.20221—
+9K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+9K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+9K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+9K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+9K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+9K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+9K213918DeGen Navigated InstrumentationDegen Medical20220—
+9K212271smart-syncNorthh Medical GmbH20220—
+9K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+9K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+9K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+9K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+9K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+9K211596CD Horizon Spinal SystemMedtronic20213—
+9K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+9K211323ASTRA Spine SystemSpinecraft, LLC202112—
+9K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+9K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+9K210306GII Spinal Fixation SystemColigne AG20210—
+9K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+9K210472SPINEART Navigation Instrument SystemSpineart20215—
+9K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+9K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+9K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—