510(k) Report

Devices descending from K950270

465 later devices reach Nmi Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971819Epoch 2000 Neurological WorkstationAxon Systems, Inc.1997464—
+2K022785Epoch XP Neurological Workstation; Epoch XP Lite Neurological WorkstationAxon Systems, Inc.2002463—
+3K032741Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc.2003462—
+4K072343Neurovision JJB SystemNuvasive, Inc.20070—
+4K050798Eclipse Neurological WorkstationAxon Systems, Inc.2005460—
+5K110410MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp.201113—
+5K061639Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and…Axon Systems, Inc.2006426—
+5K061113OrthomonAxon Systems, Inc.2006450—
+6K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+6K151354Cervello STIMBlackrock Neuromed20162—
+6K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+6K112718Nuvasive NVM5 SystemNuvasive, Inc.201235—
+6K111520Ipc Powerease SystemMedtronic Xomed, Inc.20114182
+6K110696Neuro Check Device with IO-Flex WireBaxano, Inc.20110—
+7K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+7K210637CD Horizon™ Spinal SystemMedtronic202134—
+7K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+7K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+7K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.20180—
+7K180761SD LTM STIM Cortical StimulatorMicromed S.P.A.20181—
+7K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+7K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+7K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+7K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+7K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+7K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+7K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20134041
+7K123270Powerease SystemMedtronic Sofamor Danek USA, Inc.2013398—
+7K121264Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies201212—
+8K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+8K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+8K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+8K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+8K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+8K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K242806Medyssey Navigation SystemMedyssey Co, Ltd.20250—
+8K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc.20250—
+8K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+8K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+8K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+8K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+8K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+8K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+8K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+8K230415Cadwell GuardianCadwell Industries, Inc.20230—
+8K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+8K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+8K223511Excella Navigation InstrumentsInnovasis, Inc.20233—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+8K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+8K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC20220—
+8K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+8K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+8K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+8K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+8K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+8K203816DeGen Navigated InstrumentationDegen Medical20211—
+8K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+8K202956Erisma LP Navigated InstrumentsClariance, Sas20210—
+8K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+8K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+8K202771CD Horizon Spinal SystemMedtronic202021—
+8K200845Navigation Module of the Momentum SystemUlrich Medical USA20200—