510(k) Report

Devices descending from K040360

31 later devices reach EMU128S, Model EX-NW-128S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143440Natus QuantumNatus Medical Incorporated201541
+1K110376PE-210AK Switch BoxNihon Kohden Corp.20110—
+1K082629S12X with Esax OptionChatten Associates, Inc.20094—
+1K072964Nicolet Cortical StimulatorCardinal Health, Inc.2008233
+2K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+2K180290Natus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)201811
+2K173684g.Estim PROG.Tec Medical Engineering GmbH20180—
+2K180181Natus QuantumNatus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)20181—
+2K171581Neuro Omega SystemAlpha Omega Engineering, Ltd.20172Class I
+2K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+2K151354Cervello STIMBlackrock Neuromed20162—
+2K110410MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp.201113—
+3K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+3K230415Cadwell GuardianCadwell Industries, Inc.20230—
+3K220553Neuro Omega System, NeuroSmart SystemAlpha Omega Engineering, Ltd.20221—
+3K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+3K193159NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG20200—
+3K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+3K180761SD LTM STIM Cortical StimulatorMicromed S.P.A.20181—
+4K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc.20250—
+4K250601Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering, Ltd.20250—
+4K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+4K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+4K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+4K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—