510(k) Report

Devices descending from K033160

3 later devices reach Synthes Sterile Low Profile Neuro Contourable Mesh Plates through their predicates, nearest generation first.

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