510(k) Report

Devices descending from K202198

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+1K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—