510(k) Report

Devices descending from K191906

6 later devices reach MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+1K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+1K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+2K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—