510(k) Report

Devices descending from K173025

8 later devices reach NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive®… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+1K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+1K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—