510(k) Report

Devices descending from K203038

5 later devices reach Toro-L Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+1K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+2K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+2K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—