510(k) Report

Devices descending from K984052

31 later devices reach Synergy Iom System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112052Carefusion Nicolet EdxCarefusion 209, Inc.201230—
+2K171781eVox SystemEvoke Neuroscience, Inc.20176—
+2K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.201712—
+2K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+2K120979Carefusion Nicolet EdxCarefusion 209, Inc.201212—
+3K243982Nicolet EDXNatus Neurology Incorporated20250—
+3K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated20241—
+3K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+3K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+3K192753NeuralScan SystemMedeia, Inc.20203—
+3K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+3K172743Natus VikingQuestNatus Neurology Incorporated20170—
+3K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+3K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated20133—
+4K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+4K253767UB ERP SystemUniversal Brain20260—
+4K221959Q21Neurofield, Inc.20230—
+4K230415Cadwell GuardianCadwell Industries, Inc.20230—
+4K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+4K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+4K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+4K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+5K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+5K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+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
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—