510(k) Report

Devices descending from K202065

3 later devices reach DOLOMITE Anterior Cervical Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+1K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+1K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—