510(k) Report

Devices descending from K060491

3 later devices reach Quantum Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101848Sapphire Anterior Cervical Plate SystemSpinal Elements, Inc.20102—
+2K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc.20201—
+3K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—