510(k) Report

Devices descending from K934426

47 later devices reach Nerve Integrity Monitor-2 (Nim-2 XL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061365Checkpoint with Accustim TechnologyNdi Medical, LLC20065—
+1K020955Nicolet Electrocautery DetectorNicolet Biomedical, Inc.20020—
+1K982595NIM4Xomed, Inc.199839—
+2K092292CheckpointNdi Medical, LLC20094—
+2K070608Smartep, Model M010000Intelligent Hearing Systems200716—
+2K024316Nim-PRSMedtronic Xomed, Inc.200331—
+3K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative…Checkpoint Surgical202102
+3K200886StimSiteAllotrope Medical, Inc.20200—
+3K163326SmartEPIntelligent Hearing Systems20171—
+3K150005Checkpoint, Checkpoint Head & NeckNdi Medical, LLC20151—
+3K123843Neuroepg SystemStrohl Medical Technologies201312—
+3K083371Navigator Pro with Aep Software (Biomark, Enog, Champ)Natus Medical, Inc.20090—
+3K083124NIM 3.0Medtronic Xomed, Inc.2009303
+4K253301BraiN20® (BraiN20)Time IS Brain, S.L.20260—
+4K253536Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc.20260—
+4K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc.20200Class I
+4K193033GSI Audera ProGrason Stadler20200—
+4K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+4K181559Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.201811
+4K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+4K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+4K132616EPADSafeop Surgical, Inc.201411—
+4K111647C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH20112—
+5K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+5K230415Cadwell GuardianCadwell Industries, Inc.20230—
+5K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+5K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+5K203684Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.20210—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+5K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+5K173526SENTIO MMG Gen 2Medos International SARL20182—
+5K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH201612
+6K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+6K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+6K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+6K223254C2 XploreInomed Medizintechnik GmbH20230—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+7K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—