510(k) Report

Devices descending from K162313

7 later devices reach NuVasive Next Generation NVM5 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+1K173526SENTIO MMG Gen 2Medos International SARL20182—
+2K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+2K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+3K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K230989Rod Registration FrameNu Vasive, Incorporated20230—