510(k) Report

Devices descending from K010139

14 later devices reach Zurich Distraction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170818Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC20171—
+1K163315Internal Distraction - SterileKLS Martin L.P.20170—
+1K161470Internal Distraction - SterileKLS Martin L.P.20161—
+1K133304RXG Distraction SystemKLS-Martin L.P.20140—
+1K133398Stryker Pediatric Mandible DistractorStryker20141—
+1K062572Craniotech Bone Transport Reconstruction PlateCustom Scientific20070—
+1K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP20055—
+1K013672Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC20020—
+2K220050KLS Martin IPS DistractionKLS Martin L.P.20220—
+2K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC20200—
+2K181504Stryker Pediatric Mandibular Distractor 2Stryker20180—
+2K121502Synthes Curvilinear Distraction SystemSynthes, Inc.20121—
+2K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP20062—
+3K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—