510(k) Report

Devices descending from K050443

27 later devices reach Accu-Lead through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092744Neonatal Ecg Electrode, M203KENR & D Medical Products, Inc.200926—
+2K132694Nuvasive NVM5 SystemNu Vasive, Incorporated201424—
+2K110138Paired Hydrogel ElectrodeNeurovision Medical Products, Inc.20110—
+3K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+4K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+5K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+5K152942NuVasiveNVM5 SystemNu Vasive, Incorporated201613—
+6K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+6K230415Cadwell GuardianCadwell Industries, Inc.20230—
+6K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+6K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+6K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+6K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+7K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+7K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+7K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+7K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+7K173526SENTIO MMG Gen 2Medos International SARL20182—
+8K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+8K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+9K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—