510(k) Report

Devices descending from K043434

5 later devices reach Osteomed Pediatric Intraoral Mandibular Distraction System through their predicates, nearest generation first.

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