510(k) Report

Devices descending from K994154

7 later devices reach Mod Line of Molina Distractors, 51-600 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063792Osteomed External Mandibular Distraction SystemOsteomed LP20072—
+1K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP20062—
+1K034027KLS Martin 3DX External Distraction SystemKLS-Martin L.P.20043—
+2K133398Stryker Pediatric Mandible DistractorStryker20141—
+2K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP20131—
+3K230211CranioXpandKLS-Martin L.P.20230—
+3K181504Stryker Pediatric Mandibular Distractor 2Stryker20180—