510(k) Report

Devices descending from K162431

3 later devices reach Luna 3D Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+2K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+2K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—