510(k) Report

Devices descending from K022005

5 later devices reach Synthes Midface Distractor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+1K121235Leibinger Advance Internal Midface Distraction SystemStryker20140—
+1K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial20103—
+2K133398Stryker Pediatric Mandible DistractorStryker20141—
+3K181504Stryker Pediatric Mandibular Distractor 2Stryker20180—