510(k) Report

Devices descending from K123461

25 later devices reach Staxx (R) IB System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+1K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+1K133207Staxx (R) SystemSpine Wave, Inc.20131—
+1K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+2K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+2K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+2K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+2K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+2K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+2K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+2K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+3K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+3K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+4K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+4K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—