510(k) Report

Devices descending from K151581

6 later devices reach Leva Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153222Leva Spacer SystemSpine Wave, Inc.20165—
+2K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+2K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+3K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+3K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—