510(k) Report

Devices descending from K182920

9 later devices reach MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+1K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+2K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+2K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+2K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+2K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—