510(k) Report

Devices descending from K981405

42 later devices reach Synergy LT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102610Focus Emg DeviceTeleemg, LLC USA201134—
+1K073415Nemus System; Nemus PC PeripheralEb Neuro S.P.A.200840—
+1K061828Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A.20070—
+2K232210X-trodes System MX-Trodes20240—
+2K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd.20151—
+2K142064Galileo NTEb Neuro S.P.A.20152—
+2K133517Nemus 2 SystemEb Neuro S.P.A.20141—
+2K112052Carefusion Nicolet EdxCarefusion 209, Inc.201230—
+2K083322Neurometrix BioamplifierNeurometrix, Inc.20090—
+3K242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.20240—
+3K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.20240—
+3K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd.20220—
+3K171781eVox SystemEvoke Neuroscience, Inc.20176—
+3K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.201712—
+3K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+3K120979Carefusion Nicolet EdxCarefusion 209, Inc.201212—
+4K243982Nicolet EDXNatus Neurology Incorporated20250—
+4K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated20241—
+4K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+4K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+4K192753NeuralScan SystemMedeia, Inc.20203—
+4K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+4K172743Natus VikingQuestNatus Neurology Incorporated20170—
+4K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+4K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated20133—
+5K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+5K253767UB ERP SystemUniversal Brain20260—
+5K221959Q21Neurofield, Inc.20230—
+5K230415Cadwell GuardianCadwell Industries, Inc.20230—
+5K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+5K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+5K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+6K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+6K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—