510(k) Report

Devices descending from K183184

12 later devices reach FlareHawk Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+1K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+1K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+1K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+1K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+2K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+2K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—