510(k) Report

Devices descending from K962455

37 later devices reach Four-Channel Preamplifier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112718Nuvasive NVM5 SystemNuvasive, Inc.201235—
+1K082614Evox Electro Diagnostic DeviceLaborie Medical Technologies, Inc.20090—
+2K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+2K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+2K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+2K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+3K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+3K230415Cadwell GuardianCadwell Industries, Inc.20230—
+3K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+3K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+3K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+3K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+3K132694Nuvasive NVM5 SystemNu Vasive, Incorporated201424—
+4K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+4K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+4K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+4K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+5K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+5K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+5K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+6K152942NuVasiveNVM5 SystemNu Vasive, Incorporated201613—
+7K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+7K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+8K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+8K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+8K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+8K173526SENTIO MMG Gen 2Medos International SARL20182—
+9K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+9K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+10K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—