510(k) Report

Devices descending from K131071

8 later devices reach Staxx Ibl System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+1K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+1K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+2K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+2K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+2K133207Staxx (R) SystemSpine Wave, Inc.20131—
+3K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+3K142996StaXx (R) XD SystemSpine Wave, Inc.20150—