510(k) Report

Devices descending from K182114

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+1K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+1K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+2K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—