510(k) Report

Devices descending from K982595

39 later devices reach NIM4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070608Smartep, Model M010000Intelligent Hearing Systems200716—
+1K024316Nim-PRSMedtronic Xomed, Inc.200331—
+2K163326SmartEPIntelligent Hearing Systems20171—
+2K123843Neuroepg SystemStrohl Medical Technologies201312—
+2K083371Navigator Pro with Aep Software (Biomark, Enog, Champ)Natus Medical, Inc.20090—
+2K083124NIM 3.0Medtronic Xomed, Inc.2009303
+3K253301BraiN20® (BraiN20)Time IS Brain, S.L.20260—
+3K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc.20200Class I
+3K193033GSI Audera ProGrason Stadler20200—
+3K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+3K181559Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.201811
+3K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+3K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+3K132616EPADSafeop Surgical, Inc.201411—
+3K111647C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH20112—
+4K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+4K230415Cadwell GuardianCadwell Industries, Inc.20230—
+4K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+4K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+4K203684Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.20210—
+4K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+4K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+4K173526SENTIO MMG Gen 2Medos International SARL20182—
+4K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH201612
+5K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+5K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+5K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+5K223254C2 XploreInomed Medizintechnik GmbH20230—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+5K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K230989Rod Registration FrameNu Vasive, Incorporated20230—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—