510(k) Report

Devices descending from K955026

459 later devices reach AS/3 NMT Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061113OrthomonAxon Systems, Inc.2006450—
+1K051635Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and AccessoriesGE Healthcare200571
+2K190795Tetragraph Neuromuscular Transmission MonitorSenzime AB20196—
+2K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+2K112718Nuvasive NVM5 SystemNuvasive, Inc.201235—
+2K111520Ipc Powerease SystemMedtronic Xomed, Inc.20114182
+2K110696Neuro Check Device with IO-Flex WireBaxano, Inc.20110—
+3K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+3K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…Nihon Kohden Corporation20213—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+3K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.20180—
+3K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+3K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+3K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+3K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+3K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+3K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+3K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+3K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20134041
+3K123270Powerease SystemMedtronic Sofamor Danek USA, Inc.2013398—
+3K121264Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies201212—
+4K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+4K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+4K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+4K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+4K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+4K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+4K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+4K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K242806Medyssey Navigation SystemMedyssey Co, Ltd.20250—
+4K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+4K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+4K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+4K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+4K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K230415Cadwell GuardianCadwell Industries, Inc.20230—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+4K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+4K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+4K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+4K223511Excella Navigation InstrumentsInnovasis, Inc.20233—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC20220—
+4K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+4K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000…Nihon Kohden Corporation20211—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+4K203435Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside…Nihon Kohden Corporation20210—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203816DeGen Navigated InstrumentationDegen Medical20211—
+4K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+4K202956Erisma LP Navigated InstrumentsClariance, Sas20210—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+4K202771CD Horizon Spinal SystemMedtronic202021—
+4K200845Navigation Module of the Momentum SystemUlrich Medical USA20200—
+4K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+4K200791Navigation Enabled IntrumentsMedos International SARL20205—
+4K200095Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.202004
+4K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+4K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—