510(k) Report

Devices descending from K083124

30 later devices reach NIM 3.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc.20200Class I
+1K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+1K181559Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.201811
+1K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+1K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+1K111647C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH20112—
+2K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+2K230415Cadwell GuardianCadwell Industries, Inc.20230—
+2K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+2K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+2K203684Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.20210—
+2K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+2K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+2K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+2K173526SENTIO MMG Gen 2Medos International SARL20182—
+2K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH201612
+3K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+3K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+3K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+3K223254C2 XploreInomed Medizintechnik GmbH20230—
+3K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+3K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+3K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+4K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K230989Rod Registration FrameNu Vasive, Incorporated20230—
+4K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—