510(k) Report

Devices descending from K980148

498 later devices reach Neurosign 800, 8 Channel Motor Nerve Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+5K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+5K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.20231—
+5K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+5K223511Excella Navigation InstrumentsInnovasis, Inc.20233—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K212164Mapping Suction ProbeInomed Medizintechnik GmbH20220—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+5K221244CD Horizon™ Spinal SystemMedtronic202220—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203816DeGen Navigated InstrumentationDegen Medical20211—
+5K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+5K202956Erisma LP Navigated InstrumentsClariance, Sas20210—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+5K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc.20200Class I
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K200845Navigation Module of the Momentum SystemUlrich Medical USA20200—
+5K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+5K200791Navigation Enabled IntrumentsMedos International SARL20205—
+5K200095Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.202004
+5K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+5K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K181606Precision Spine Navigation InstrumentationPrecision Spine, Inc.20193—
+5K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+5K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+5K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+5K181559Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.201811
+5K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionMedtronic Sofamor Danek USA, Inc.201841—
+5K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+5K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+5K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+5K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+5K173526SENTIO MMG Gen 2Medos International SARL20182—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K171267NavLock TrackersMedtronic Navigation201741
+5K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions201711—
+5K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+5K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC20170—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K153603Alphatec Navigation InstrumentsAlphatec Spine, Inc.201679—
+5K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+5K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+5K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+5K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc.2015206—
+5K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+5K092729Baxano Neuro Check DeviceBaxano, Inc.20091—
+6K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.20260—
+6K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…Tedan Surgical Innovations20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—