510(k) Report

Devices descending from K003883

9 later devices reach Molina Orbital Malar Distractor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161470Internal Distraction - SterileKLS Martin L.P.20161—
+1K121235Leibinger Advance Internal Midface Distraction SystemStryker20140—
+1K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP20131—
+1K121304Osteomed Cranial Distraction SystemOsteomed20122—
+1K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial20103—
+2K230211CranioXpandKLS-Martin L.P.20230—
+2K220050KLS Martin IPS DistractionKLS Martin L.P.20220—
+2K133398Stryker Pediatric Mandible DistractorStryker20141—
+3K181504Stryker Pediatric Mandibular Distractor 2Stryker20180—