510(k) Report

Devices descending from K013618

6 later devices reach Intraoral Mandibular Distraction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121502Synthes Curvilinear Distraction SystemSynthes, Inc.20121—
+1K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP20055—
+2K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+2K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP20062—
+3K133398Stryker Pediatric Mandible DistractorStryker20141—
+4K181504Stryker Pediatric Mandibular Distractor 2Stryker20180—