510(k) Report

Devices descending from K181397

15 later devices reach DualX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+1K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+1K211740DualXAmplify Surgical, Inc.20211—
+1K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+1K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+2K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+2K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+2K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+3K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+3K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—