510(k) Report

Devices descending from K060138

5 later devices reach Synthes (Usa) Craniomaxillofacial Distraction System 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—
+1K170818Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC20171—
+1K162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC20170—
+1K121502Synthes Curvilinear Distraction SystemSynthes, Inc.20121—