510(k) Report

Devices descending from K201367

2 later devices reach FlareHawk TiHawk9 Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+2K250769Dakota LP SystemPrecision Spine, Inc.20250—