510(k) Report

Devices descending from K152972

3 later devices reach Amendia Stand-Alone Cervical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+1K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+2K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—