510(k) Report

Devices descending from K143641

22 later devices reach NuVasive NVM5 System through their predicates, nearest generation first.

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