510(k) Report

Devices descending from K180401

5 later devices reach TiWAVE-C™ Porous Titanium Cervical Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+1K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+1K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+2K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+2K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—