510(k) Report

Devices descending from K222203

3 later devices reach DualXSLIM (R) T/PLIF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+2K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+2K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—