510(k) Report

Devices descending from K031807

4 later devices reach Synthes Low Profile Neuro System - 3 MM Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC20200—
+1K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+1K123723Synthes Matrixneuro Cranial Plating SystemSynthes20132—
+2K140462Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System)Synthes (USA) Products, LLC20141—